Cynosure, Inc. · Lasers & Light
510(k) · clearedClass IIK034030
Cleared2000Studies744Trials30
Devices linked to hair removal
16 products · matched by keyword rule, not the cleared indication
16 products
Sciton, Inc · Lasers & Light
510(k) · clearedClass IIK032460
Cleared2003Studies1,028Trials43
Lutronic Corporation · Lasers & Light
510(k) · clearedClass IIK183566EU
Cleared2013Studies744Trials30
Inmode MD , Ltd. · Lasers & Light
510(k) · clearedClass IIK180719
Cleared2015Studies744Trials30
Cynosure, LLC · Lasers & Light
510(k) · clearedClass IIK240396
Cleared2020Studies744Trials30
Candela Corp. · Lasers & Light
510(k) · clearedClass IIK140732EU
Cleared1997Studies744Trials30
Candela Corporation · Lasers & Light
510(k) · clearedClass IIK201111EU
Cleared2011Studies744Trials30
Alma Lasers, Inc. · Lasers & Light
510(k) · clearedClass IIK243044
Cleared2008Studies1,028Trials43
Cynosure, Inc. · Lasers & Light
510(k) · clearedClass IIK142376EU
Cleared2011Studies1,028Trials43
Lumenis, Ltd. · Lasers & Light
510(k) · clearedClass IIK170179EU
Cleared1998Studies744Trials30
El.En S.P.A. · Lasers & Light
510(k) · clearedClass IIK241459EU
Cleared2017Studies744Trials30
Candela Corporation · Lasers & Light
510(k) · clearedClass IIK212492EU
Cleared2015Studies1,028Trials43
Alma Lasers, Inc. · Lasers & Light
510(k) · clearedClass IIK230371EU
Cleared2009Studies744Trials30
Bios S.R.L. · Lasers & Light
510(k) · clearedClass IIK243445EU
Cleared2024Studies744Trials30
Lumenis Be, Ltd. · Lasers & Light
510(k) · clearedClass IIK250809EU
Cleared2015Studies1,028Trials43
Palomar Medical Technologies, Inc. · Lasers & Light
510(k) · clearedClass IIK120622EU
Cleared2012Studies744Trials30
| Product | Manufacturer | Category | Pathway | Class | First decision | Studies | Trials |
|---|---|---|---|---|---|---|---|
| Apogee Elite | Cynosure, Inc. | Lasers & Light | 510(k) — cleared | Class II | Jun 29 2000 | 744 | 30 |
| BBL | Sciton, Inc | Lasers & Light | 510(k) — cleared | Class II | Nov 13 2003 | 1,028 | 43 |
| Clarity II EU | Lutronic Corporation | Lasers & Light | 510(k) — cleared | Class II | Nov 22 2013 | 744 | 30 |
| Diolaze | Inmode MD , Ltd. | Lasers & Light | 510(k) — cleared | Class II | Jan 13 2015 | 744 | 30 |
| Elite iQ | Cynosure, LLC | Lasers & Light | 510(k) — cleared | Class II | Mar 9 2020 | 744 | 30 |
| GentleLase EU | Candela Corp. | Lasers & Light | 510(k) — cleared | Class II | Dec 4 1997 | 744 | 30 |
| GentleMax Pro EU | Candela Corporation | Lasers & Light | 510(k) — cleared | Class II | Oct 5 2011 | 744 | 30 |
| Harmony XL | Alma Lasers, Inc. | Lasers & Light | 510(k) — cleared | Class II | May 23 2008 | 1,028 | 43 |
| Icon EU | Cynosure, Inc. | Lasers & Light | 510(k) — cleared | Class II | Jun 22 2011 | 1,028 | 43 |
| LightSheer EU | Lumenis, Ltd. | Lasers & Light | 510(k) — cleared | Class II | May 4 1998 | 744 | 30 |
| Motus EU | El.En S.P.A. | Lasers & Light | 510(k) — cleared | Class II | Jun 19 2017 | 744 | 30 |
| Nordlys EU | Candela Corporation | Lasers & Light | 510(k) — cleared | Class II | Jul 7 2015 | 1,028 | 43 |
| Soprano EU | Alma Lasers, Inc. | Lasers & Light | 510(k) — cleared | Class II | Apr 14 2009 | 744 | 30 |
| Splendor X EU | Bios S.R.L. | Lasers & Light | 510(k) — cleared | Class II | Jun 14 2024 | 744 | 30 |
| Stellar M22 EU | Lumenis Be, Ltd. | Lasers & Light | 510(k) — cleared | Class II | Jan 21 2015 | 1,028 | 43 |
| Vectus EU | Palomar Medical Technologies, Inc. | Lasers & Light | 510(k) — cleared | Class II | May 23 2012 | 744 | 30 |
No product matches these filters.
Missing a device? Report it and it goes into the monthly review.
Curated seed list; study and trial counts are per modality, not per brand. What this measuresThis is a curated seed list of widely used medical-aesthetic products, each crosswalked to a real FDA record where one could be found with confidence. Being listed is not an endorsement, not a ranking and not a claim of market share. Being absent is not a judgement — it means the product is not in this seed list yet. Counts beside each filter are live counts of the products currently matching your other filters. Manufacturer is the applicant or sponsor field of the FDA record, printed exactly as FDA publishes it, so one company can appear under more than one string.
Methodology →
Sorted by most recent FDA decision — a filing date, not a quality signal. What each ordering measuresEvery ordering on this page is a proxy built from public records, never a quality judgement. Orders products by the most recent FDA decision date matched to the brand name, including later submissions and supplements. A recent date means the manufacturer filed again; it does not mean the product is newer, improved, more popular or better. Orders products by the number of PubMed records matching a fixed query for the product's MODALITY, never its brand name. It counts 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 techniques of different ages. Orders products by the number of ClinicalTrials.gov studies matching a fixed intervention-plus-condition query for the product's MODALITY, never its brand. Registration is not completion, not publication and not a result. Alphabetical by product name. No ranking, quality judgement or ordering of merit is implied by the position of anything in this list. Orders products by the earliest FDA decision date matched to the brand name. For drugs approved under a BLA or NDA the original approval can long predate any cosmetic indication, so an early date is not a cosmetic-use date.
Methodology →
How each product matched (16)
| Product | Matched term | Source string |
|---|---|---|
| Apogee Elite | hair removal | ClinicalTrials.gov condition query for Laser hair removal |
| BBL | hirsutism | ClinicalTrials.gov condition query for IPL / broadband light |
| Clarity II | hair removal | ClinicalTrials.gov condition query for Laser hair removal |
| Diolaze | hair removal | ClinicalTrials.gov condition query for Laser hair removal |
| Elite iQ | hair removal | ClinicalTrials.gov condition query for Laser hair removal |
| GentleLase | hair removal | ClinicalTrials.gov condition query for Laser hair removal |
| GentleMax Pro | hair removal | ClinicalTrials.gov condition query for Laser hair removal |
| Harmony XL | hirsutism | ClinicalTrials.gov condition query for IPL / broadband light |
| Icon | hirsutism | ClinicalTrials.gov condition query for IPL / broadband light |
| LightSheer | hair removal | ClinicalTrials.gov condition query for Laser hair removal |
| Motus | hair removal | ClinicalTrials.gov condition query for Laser hair removal |
| Nordlys | hirsutism | ClinicalTrials.gov condition query for IPL / broadband light |
| Soprano | hair removal | ClinicalTrials.gov condition query for Laser hair removal |
| Splendor X | hair removal | ClinicalTrials.gov condition query for Laser hair removal |
| Stellar M22 | hirsutism | ClinicalTrials.gov condition query for IPL / broadband light |
| Vectus | hair removal | ClinicalTrials.gov condition query for Laser hair removal |
Derived by keyword rule from real source strings, not the cleared indication. What this measuresTreatment 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. Products whose source query or FDA product code names hair removal, unwanted hair, hirsutism or pseudofolliculitis.
Methodology →