Sofwave and Ultherapy — what the public records differ on
Both are ultrasound lifting & tightening products · 5 of 11 compared fields differ
Both are ultrasound lifting & tightening products, so the published evidence behind them is one shared body of work: 317 papers on PubMed and 16 studies registered on ClinicalTrials.gov, counted for the technique and not for either name. What differs is the record. Sofwave (Sofwave Medical, Ltd.) is FDA cleared under a 510(k): record K250146, first cleared Nov 15 2021, 10 FDA records in all, the most recent Apr 18 2025. Ultherapy (Ulthera, Inc.) is FDA cleared under a 510(k): record K260618, first cleared Sep 11 2009, 10 FDA records in all, the most recent May 21 2026. Ultherapy carries the earlier first decision by 12 years — 2009 against 2021. An earlier date is a longer paper trail, not a better product. 5 of the 11 compared fields differ; the highlighted rows below are exactly those fields, and a highlighted row is a difference in the public records, never a judgement about a product.
Field by field
| Field | SofwaveBody Contouring | UltherapyBody Contouring | |
|---|---|---|---|
| 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 → | Sofwave Medical, Ltd. | Ulthera, Inc. | |
| 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 → | Body Contouring | Body Contouring | |
| 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 → | 510(k) · cleared | 510(k) · cleared | |
| 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 → | Class II | Class II | |
| 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 → | cleared | cleared | |
| 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 → | 5 | 17 | |
| 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 → | K250146 → | K260618 → | |
| 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 → | Wrinkles & linesSkin laxityPhotoaging & rejuvenationMuscle stimulation | Wrinkles & linesSkin laxityPhotoaging & rejuvenation | |
| 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 → | 317 | 317 | |
| 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 → | 16 | 16 | |
| 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 → | 1 | 1 | |
| 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 → | EUrecord → |
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. A 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 →
Study and trial figures on this site are counted per TECHNIQUE, never per brand. One fixed query is run for the modality and the brand name appears nowhere inside it, so every product that shares a technique carries exactly the same number. That identical figure is EXPECTED and it is not a claim about either product: it is not a finding that they are equivalent, not a measurement of either one, and not evidence that one works as well as the other. It is a fact about the published literature and nothing else. Brand-name literature searches were rejected for the opposite reason — they reward the manufacturer with the larger marketing department and punish an equally well-built product with a quieter name.
What the FDA records show that the studies do not
Sofwave
Sofwave (Sofwave Medical, Ltd.) is FDA cleared under a 510(k): record K250146, first cleared Nov 15 2021, 10 FDA records in all, the most recent Apr 18 2025.
Ultherapy
Ultherapy (Ulthera, Inc.) is FDA cleared under a 510(k): record K260618, first cleared Sep 11 2009, 10 FDA records in all, the most recent May 21 2026.
Counted for the technique, from one fixed query the brand name is not in. What this measuresNumber of PubMed records matching a fixed, hand-written title/abstract query for the MODALITY, not the brand. 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 across modalities of different ages -- an older technique has had more years to accumulate papers. Query text is stored next to every count so you can run it yourself. 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 →
Nearby comparisons
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 →
Assembled by a program from public records; no figure here was written by hand. What this measuresThis page was assembled by a program from the public records this Index already holds: the openFDA 510(k) and PMA releasable databases, PubMed counts and ClinicalTrials.gov counts, on the run date printed at the top. No sentence on it was written about these products by hand, no figure was estimated, and a value the source does not publish is an em-dash carrying the reason rather than a filled-in guess. Which products appear beside each other is an editorial choice about observed search demand, described in the note beside it. Putting two products on one page is not a recommendation for or against either of them.
Methodology →