Compare aesthetic devices on their FDA records
All productsUp to 4 products side by side, on the same public records their own pages cite.
0 products
| Product |
|---|
| ManufacturerManufacturerThe applicant or sponsor field of the matched FDA record, printed exactly as FDA publishes it. One company can appear under more than one string — a trading name, a former name, a subsidiary — so two products from the same company can read as different in this row. It is not tidied up here, because tidying it would mean printing something FDA did not. Methodology → |
| CategoryCategoryThis Index's own five-way grouping, used for navigation. It is not an FDA classification, not a clinical taxonomy and not a statement that two products in one group are interchangeable. Methodology → |
| FDA pathwayFDA pathwayA 510(k) is a CLEARANCE: FDA agreed the device is substantially equivalent to a device already legally on the market. It is not an approval, not a finding that the device is effective, and not a comparison against any other product. PMA, BLA and NDA products are APPROVED: FDA reviewed the manufacturer's own clinical evidence. A product with no matched FDA record claims no pathway at all here. A different pathway is a different regulatory route, not a better or a worse product. Methodology → |
| Device classDevice classFDA's risk class, read from the classification record of the product codes on the matched FDA records. A drug approved under a BLA or an NDA has no device class at all. A higher class means FDA applies more regulatory controls to that kind of device; it is not a quality, performance or safety score. Methodology → |
| First cleared / approvedFirst cleared / approvedThe earliest FDA decision date matched to this brand name. The verb beside each date is read from that record's own pathway: 510(k) records are cleared, PMA, BLA and NDA records are approved. For a drug approved under a BLA or an NDA the original approval can long predate any cosmetic indication, so an early date here is not a cosmetic-use date. Methodology → |
| Years on marketYears on marketDerived: the data run date minus the first matched FDA decision date. Arithmetic on a real date, nothing else. It is not how long the product in its current form has been sold, and a longer figure is not a quality signal. Methodology → |
| Primary identifierPrimary identifierThe clearance or approval number this Index treats as the product's primary FDA record. It links straight to the FDA public record so the entry can be read at source. A product can hold many identifiers; the rest are listed on its own page. Methodology → |
| Treatment areasTreatment areasTreatment areas are DERIVED, not copied from an FDA field. A fixed keyword list is run over two real strings: the ClinicalTrials.gov condition query actually executed for this product's modality on the run date, and the device names of the FDA product codes attached to this product's records. The words "skin" and "cosmetic" are ignored because every query contains one of them. An area is not the cleared or approved indication — openFDA's 510(k) response does not carry the indications-for-use text, and this Index does not paraphrase it. Methodology → |
| Studies (PubMed)Studies (PubMed)Counted per TREATMENT, not per brand. This figure comes from one fixed query about the product's modality — the technique — and the brand name never appears anywhere in that query. Two products that share a modality therefore carry exactly the same number in this row, and that identical figure is expected: it is not a finding that the two products are equivalent, not a measurement of either one, and not a claim about either product. It measures how much has been published about a technique. It is not a quality score, not an efficacy measure, not a count of randomised trials, and not comparable between modalities of different ages. It says nothing about this brand specifically. Methodology → |
| Trials registeredTrials registeredCounted per TREATMENT, not per brand. This figure comes from one fixed query about the product's modality — the technique — and the brand name never appears anywhere in that query. Two products that share a modality therefore carry exactly the same number in this row, and that identical figure is expected: it is not a finding that the two products are equivalent, not a measurement of either one, and not a claim about either product. Registration is not completion, not publication and not a result. Counts include studies of any status, size or sponsor, and the recruiting figure is a snapshot taken on the run date. Device studies are under-registered relative to drug studies. Methodology → |
| Trials recruitingTrials recruitingCounted per TREATMENT, not per brand. This figure comes from one fixed query about the product's modality — the technique — and the brand name never appears anywhere in that query. Two products that share a modality therefore carry exactly the same number in this row, and that identical figure is expected: it is not a finding that the two products are equivalent, not a measurement of either one, and not a claim about either product. Registration is not completion, not publication and not a result. Counts include studies of any status, size or sponsor, and the recruiting figure is a snapshot taken on the run date. Device studies are under-registered relative to drug studies. Methodology → |
| EUDAMEDEUDAMEDA badge in this row means this Index matched the product to a record in EUDAMED, the EU device database, on the run date. A blank cell means only that this Index could not match one, and nothing else: EUDAMED registration became mandatory in May 2026 with a transition period running to November 2026, so a product with a blank cell here may still be CE marked and on sale in the EU. A EUDAMED entry is a registration, not an FDA-style clearance or approval, and says nothing about safety, efficacy or quality. This row is never counted as a difference. Methodology → |
Highlighted rows are differences in the public records, not quality judgements. What this measuresEvery cell on this page is the same value the product's own page shows, copied mechanically from the public source record it cites — openFDA, PubMed or ClinicalTrials.gov — and a value the source does not publish is an em-dash, never an estimate. A highlighted row marks a place where those SOURCE RECORDS differ, not a place where one product is better: a different pathway, class or date is a different regulatory route, and study and trial counts are counted per modality, never per brand. Putting two products beside each other is not a recommendation for or against either of them, and the order of the columns is the order you picked them in. A row is highlighted when the selected products do not all carry the same value in it, and a row where every selected product carries the same value stays unmarked. An older first-decision date is not a worse product. The EUDAMED row is never marked, because a blank cell there records only what this Index could not match.
Methodology →
A badge means we matched a EUDAMED record; a blank cell means only that we could not. EUDAMEDA badge in this row means this Index matched the product to a record in EUDAMED, the EU device database, on the run date. A blank cell means only that this Index could not match one, and nothing else: EUDAMED registration became mandatory in May 2026 with a transition period running to November 2026, so a product with a blank cell here may still be CE marked and on sale in the EU. A EUDAMED entry is a registration, not an FDA-style clearance or approval, and says nothing about safety, efficacy or quality. This row is never counted as a difference.
Methodology →
Nothing is selected yet. Pick products with the box above, or tick the small box in the corner of any card on Modalities — a selection follows you around the site and lands here.
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One product selected. Add at least one more to see them side by side.
Comparisons with a page of their own
Written out in full, so they can be read, linked and cited without assembling a selection.
A product against its technique
Accent vs RF body contouring
Agnes RF vs microneedling
BBL vs IPL
Botox Cosmetic vs botulinum toxin
Clear + Brilliant vs fractional laser
CoolSculpting vs cryolipolysis
CoolSculpting Elite vs cryolipolysis
CoolTone vs muscle stimulation
Daxxify vs botulinum toxin
Dysport vs botulinum toxin
Emerald Laser vs laser lipolysis
Emsculpt NEO vs muscle stimulation
Exilis vs RF body contouring
Fraxel vs fractional laser
Halo vs fractional ablative laser
Jeuveau vs botulinum toxin
Morpheus8 vs microneedling
NuEra Tight vs RF body contouring
PicoCare vs picosecond laser
PicoSure vs picosecond laser
PicoWay vs picosecond laser
Potenza vs microneedling
Profhilo vs hyaluronic acid filler
Scarlet SRF vs microneedling
SculpSure vs laser lipolysis
SkinPen vs microneedling
Sofwave vs ultrasound skin tightening
Soprano vs laser hair removal
Stellar M22 vs IPL
Sylfirm X vs microneedling
TempSure vs RF skin tightening
Thermage vs RF skin tightening
truSculpt vs RF body contouring
Ultherapy vs ultrasound skin tightening
VelaShape vs RF body contouring
Venus Legacy vs RF body contouring
Vivace vs microneedling
Volnewmer vs RF skin tightening
Xeomin vs botulinum toxin
A product against another product
Botox Cosmetic vs Daxxify
Botox Cosmetic vs Dysport
Botox Cosmetic vs Jeuveau
Botox Cosmetic vs Xeomin
Clear + Brilliant vs Fraxel
CoolSculpting vs CoolSculpting Elite
CoolSculpting vs CoolTone
CoolSculpting vs Emsculpt NEO
CoolSculpting vs SculpSure
CoolTone vs Emsculpt NEO
Emsculpt NEO vs SculpSure
Emsculpt NEO vs truSculpt
Fraxel vs Halo
Morpheus8 vs Potenza
Morpheus8 vs Sculptra
Morpheus8 vs SkinPen
Morpheus8 vs Sofwave
Morpheus8 vs Thermage
Morpheus8 vs Ultherapy
Morpheus8 vs Vivace
PicoSure vs PicoWay
Potenza vs SkinPen
Potenza vs Thermage
Potenza vs Vivace
SkinPen vs Vivace
Sofwave vs Thermage
Sofwave vs Ultherapy
Sylfirm X vs Vivace
Thermage vs Ultherapy
Which pairs exist is editorial — observed search demand, not a judgement about any product. What this measuresWhich brands get a comparison page is the ONE editorial decision on this site, and this is it stated plainly. Every brand with a comparison page was observed in a live Google or Bing autocomplete list on 2026-07-26 — that is the entire membership rule, and the seed query each brand was seen under is published in the source of this page. It is a record of what people type, not a judgement about the products: a brand with a page is not better, more popular or more recommended than a brand without one, and a brand without one is missing only because nobody has yet seen it in an autocomplete list. Nothing else on this site is chosen this way; every figure on the page below is copied mechanically from a public record.
Methodology →
A pair is published only when the records differ in at least 4 compared fields. What this measuresA pair only gets a page of its own when the public records actually differ in at least 4 of the 11 compared fields. Two products built on one technique share every study and trial figure by construction, so a pair that differs in fewer than that would be one template with two names swapped into it — and it is not published here at all. Those pairs stay available in the comparison builder, which assembles them in your browser on request. A highlighted row marks a place where the SOURCE RECORDS differ; it is not a score, not a winner and not a recommendation, and an older first-decision date is not a worse product.
Methodology →
Accure Acne, Inc.
510(k) · cleared
Class II
cleared
4
66
5
1
Lumenis, Ltd.
510(k) · cleared
Class II
cleared
18
1,485
229
13
EUrecord →
Aerolase Medical Lasers, LLC
510(k) · cleared
Class II
cleared
14
—
—
—
—
—
No US authorization
—
—
—
—
450
49
6
Agnes Medical Co., Ltd.
510(k) · cleared
Class II
cleared
9
354
37
1
GALDERMA LABS LP
NDA · approved
—
approved
7
4,253
343
14
Alma Lasers, Inc.
510(k) · cleared
Class II
cleared
19
255
0
0
EUrecord →
Alma Lasers, Inc.
510(k) · cleared
Class II
cleared
5
1,485
229
13
EUrecord →
Cynosure, Inc.
510(k) · cleared
Class II
cleared
26
744
30
1
—
No US authorization
—
—
—
—
2,396
79
18
Revelle Aesthetics, Inc.
510(k) · cleared
Class II
cleared
4
50
4
0
Cutera, Inc.
510(k) · cleared
Class II
cleared
4
66
5
1
EUrecord →
Sciton, Inc
510(k) · cleared
Class II
cleared
23
1,028
43
5
Tiger Aesthetics Medical, LLC
PMA · approved
—
approved
20
—
—
—
—
Merz North America, Inc.
PMA · approved
—
approved
15
1,298
46
3
Merz North America, Inc.
PMA · approved
—
approved
0
1,298
46
3
Merz North America, Inc.
PMA · approved
—
approved
0
1,298
46
3
Sun Pharmaceutical Industries, Inc.
510(k) · cleared
Class II
cleared
23
—
—
—
—
ALLERGAN
BLA · approved
—
approved
35
2,201
186
4
Ulthera, Inc.
510(k) · cleared
Class II
cleared
11
50
4
0
—
No US authorization
—
—
—
—
158
106
12
Cynosure, Inc.
510(k) · cleared
Class II
cleared
14
50
4
0
EUrecord →
Biophotas, Inc.
510(k) · cleared
Class II
cleared
12
—
—
—
EUrecord →
Lutronic Corporation
510(k) · cleared
Class II
cleared
13
744
30
1
EUrecord →
Solta Medical, Inc.
510(k) · cleared
Class II
cleared
15
1,157
128
10
EUrecord →
Syneron-Candela Corp
510(k) · cleared
Class II
cleared
11
1,485
229
13
Zeltiq Aesthetics, Inc.
510(k) · cleared
Class II
cleared
14
245
20
0
Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics
510(k) · cleared
Class II
cleared
5
245
20
0
EUrecord →
Zimmer Medizinsysteme GmbH
510(k) · cleared
Class II
cleared
7
61
4
0
Cynosure, Inc.
510(k) · cleared
Class II
cleared
21
1,530
72
3
EUrecord →
REVANCE THERAPEUTICS, INC.
BLA · approved
—
approved
4
2,201
186
4
GALDERMA LABS LP
NDA · approved
—
approved
30
4,253
343
14
Inmode MD , Ltd.
510(k) · cleared
Class II
cleared
11
744
30
1
Quanta System Spa
510(k) · cleared
Class II
cleared
10
323
27
0
EUrecord →
IPSEN BIOPHARM LTD
BLA · approved
—
approved
17
2,201
186
4
Lutronic Corporation
510(k) · cleared
Class II
cleared
18
1,485
229
13
Cynosure, LLC
510(k) · cleared
Class II
cleared
6
744
30
1
Cytrellis Biosystems, Inc.
510(k) · cleared
Class II
cleared
1
619
135
13
—
No US authorization
—
—
—
—
—
—
—
—
—
No US authorization
—
—
—
—
158
106
12
—
Unverified mapping
—
—
—
—
61
4
0
Endymed Medical, Ltd.
510(k) · cleared
Class II
cleared
12
354
37
1
Cutera, Inc.
510(k) · cleared
Class II
cleared
10
323
27
0
EUrecord →
Erchonia Corporation
510(k) · cleared
Class II
cleared
6
112
0
0
BTL Industries, Inc.
510(k) · cleared
Class II
cleared
17
255
0
0
Invasix , Ltd.
510(k) · cleared
Class II
cleared
15
354
37
1
Candela Corporation
510(k) · cleared
Class II
cleared
10
1,157
128
10
EUrecord →
Solta Medical
510(k) · cleared
Class II
cleared
21
1,157
128
10
EUrecord →
Candela Corp.
510(k) · cleared
Class II
cleared
29
744
30
1
EUrecord →
Candela Corporation
510(k) · cleared
Class II
cleared
15
744
30
1
EUrecord →
—
Unverified mapping
—
—
—
—
1,485
229
13
Alma Lasers, Inc.
510(k) · cleared
Class II
cleared
18
1,028
43
5
Lutronic Corporation
510(k) · cleared
Class II
cleared
19
—
—
—
—
EUrecord →
—
Unverified mapping
—
—
—
—
166
9
0
HALOZYME THERAP
BLA · approved
—
approved
21
—
—
—
—
Cynosure, Inc.
510(k) · cleared
Class II
cleared
15
1,028
43
5
EUrecord →
Jeisys Medical, Inc.
510(k) · cleared
Class II
cleared
10
354
37
1
EVOLUS INC
BLA · approved
—
approved
7
2,201
186
4
—
No US authorization
—
—
—
—
158
106
12
Allergan
PMA · approved
—
approved
16
1,298
46
3
Allergan
PMA · approved
—
approved
10
1,298
46
3
Allergan
PMA · approved
—
approved
9
1,298
46
3
Allergan
PMA · approved
—
approved
13
1,298
46
3
Allergan
PMA · approved
—
approved
4
1,298
46
3
ABBVIE
NDA · approved
—
approved
11
—
—
—
—
Lutronic Global
510(k) · cleared
Class II
cleared
9
1,157
128
10
EUrecord →
ABBVIE
NDA · approved
—
approved
18
128
28
0
HUGEL INC
BLA · approved
—
approved
2
2,201
186
4
Lumenis, Ltd.
510(k) · cleared
Class II
cleared
28
744
30
1
EUrecord →
Led Intellectual Properties, LLC
510(k) · cleared
Class II
cleared
16
—
—
—
EUrecord →
Cynosure Lutronic Technology Corporation
510(k) · cleared
Class II
cleared
8
354
37
1
EUrecord →
Lutronic Corporation
510(k) · cleared
Class II
cleared
13
354
37
1
Eclipse Medcorp, LLC
510(k) · cleared
Class II
cleared
5
619
135
13
InMode , Ltd.
510(k) · cleared
Class II
cleared
7
354
37
1
EUrecord →
El.En S.P.A.
510(k) · cleared
Class II
cleared
9
744
30
1
EUrecord →
Candela Corporation
510(k) · cleared
Class II
cleared
11
1,028
43
5
EUrecord →
Bios S.R.L.
510(k) · cleared
Class II
cleared
6
255
0
0
EUrecord →
Globalmed Technologies
510(k) · cleared
Class II
cleared
23
—
—
—
Wontech Co., Ltd.
510(k) · cleared
Class II
cleared
9
323
27
0
Lutronic Corporation
510(k) · cleared
Class II
cleared
8
323
27
0
Cynosure, LLC
510(k) · cleared
Class II
cleared
14
323
27
0
EUrecord →
Candela Corporation
510(k) · cleared
Class II
cleared
11
323
27
0
EUrecord →
Jeisys Medical, Inc.
510(k) · cleared
Class II
cleared
6
354
37
1
EUrecord →
—
No US authorization
—
—
—
—
1,298
46
3
Candela Corporation
510(k) · cleared
Class II
cleared
10
354
37
1
Merz North America, Inc.
PMA · approved
—
approved
20
582
7
0
—
No US authorization
—
—
—
—
155
16
2
Refine USA, LLC
510(k) · cleared
Class II
cleared
6
619
135
13
VALEANT PHARMS NORTH
NDA · approved
—
approved
26
4,253
343
14
Q-Med AB
PMA · approved
—
approved
10
1,298
46
3
EUrecord →
Q-Med AB
PMA · approved
—
approved
6
1,298
46
3
EUrecord →
Q-Med AB
PMA · approved
—
approved
11
1,298
46
3
EUrecord →
Q-Med AB
PMA · approved
—
approved
12
1,298
46
3
BAUSCH
NDA · approved
—
approved
53
4,253
343
14
Prollenium Medical Technologies, Inc.
PMA · approved
—
approved
9
1,298
46
3
Cynosure, Inc.
510(k) · cleared
Class II
cleared
20
—
—
—
—
EUrecord →
Teoxane S.A.
PMA · approved
—
approved
9
1,298
46
3
KENVUE BRANDS
NDA · approved
—
approved
38
—
—
—
—
VIOL Co., Ltd.
510(k) · cleared
Class II
cleared
8
354
37
1
Cynosure
510(k) · cleared
Class II
cleared
11
112
0
0
Q-Med AB
PMA · approved
—
approved
22
586
17
0
EUrecord →
Ilooda Co,., Ltd.
510(k) · cleared
Class II
cleared
3
354
37
1
Ilooda Co,., Ltd.
510(k) · cleared
Class II
cleared
9
354
37
1
Crown Aesthetics
510(k) · cleared
Class II
cleared
8
619
135
13
EUrecord →
Esthetic Medical, Inc.
510(k) · cleared
Class II
cleared
6
619
135
13
Allergan
PMA · approved
—
approved
3
1,298
46
3
El.En S.P.A.
510(k) · cleared
Class II
cleared
23
1,485
229
13
EUrecord →
Sofwave Medical, Ltd.
510(k) · cleared
Class II
cleared
5
317
16
1
EUrecord →
Alma Lasers, Inc.
510(k) · cleared
Class II
cleared
17
744
30
1
EUrecord →
Fotona D.O.O.
510(k) · cleared
Class II
cleared
15
1,485
229
13
Bios S.R.L.
510(k) · cleared
Class II
cleared
2
744
30
1
EUrecord →
Lumenis Be, Ltd.
510(k) · cleared
Class II
cleared
11
1,028
43
5
EUrecord →
VIOL Co., Ltd.
510(k) · cleared
Class II
cleared
6
354
37
1
EUrecord →
ALMIRALL
NDA · approved
—
approved
29
4,253
343
14
Cynosure, LLC
510(k) · cleared
Class II
cleared
9
432
9
1
EUrecord →
Solta Medical
510(k) · cleared
Class II
cleared
26
432
9
1
EUrecord →
Jeisys Medical Incorporated
510(k) · cleared
Class II
cleared
1
—
—
—
—
GALDERMA LABS LP
NDA · approved
—
approved
24
1,116
51
4
Cutera, Inc.
510(k) · cleared
Class II
cleared
14
255
0
0
EUrecord →
Johari Digital Healthcare Limited
510(k) · cleared
Class II
cleared
4
—
—
—
Cutera, Inc.
510(k) · cleared
Class II
cleared
4
255
0
0
EUrecord →
Ulthera, Inc.
510(k) · cleared
Class II
cleared
17
317
16
1
Lumenis Be, Ltd.
510(k) · cleared
Class II
cleared
35
1,485
229
13
EUrecord →
Syneron Medical, Ltd.
510(k) · cleared
Class II
cleared
12
—
—
—
—
Candela Corporation
510(k) · cleared
Class II
cleared
24
1,530
72
3
EUrecord →
Palomar Medical Technologies, Inc.
510(k) · cleared
Class II
cleared
14
744
30
1
EUrecord →
Syneron Medical, Ltd.
510(k) · cleared
Class II
cleared
19
255
0
0
Venus Concept USA, Inc.
510(k) · cleared
Class II
cleared
7
112
0
0
Venus Concept USA, Inc.
510(k) · cleared
Class II
cleared
11
255
0
0
Venus Concept USA, Inc.
510(k) · cleared
Class II
cleared
11
354
37
1
ShenB Co., Ltd.
510(k) · cleared
Class II
cleared
5
354
37
1
ShenB Co., Ltd.
510(k) · cleared
Class II
cleared
10
354
37
1
EUrecord →
Classys, Inc.
510(k) · cleared
Class II
cleared
2
432
9
1
EUrecord →
SUN PHARM
NDA · approved
—
approved
6
90
21
2
MERZ PHARMS
BLA · approved
—
approved
16
2,201
186
4
Erchonia Corporation
510(k) · cleared
Class II
cleared
14
112
0
0