Alma Lasers, Inc.
510(k) · clearedClass IIK101147EU
Cleared2007Studies255Trials0
Sofwave — FDA clearance record and published evidence
Sofwave Medical, Ltd. · Body Contouring · Ultrasound lifting & tightening
510(k) · clearedClass IIK250146
PathwayPathwayA 510(k) clearance means FDA agreed the device is substantially equivalent to a device already legally on the market. It is a clearance, not an approval: it is not a finding that the device is effective, and not a comparison against any other product.
Methodology →510(k) · cleared
Methodology →510(k) · cleared
ClassII
First cleared2021
Years on marketYears on marketDerived: the data run date minus the first matched FDA decision date. Arithmetic on a real date, nothing else.
Methodology →5
Methodology →5
StudiesStudiesPubMed records for a fixed query about 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 between modalities of different ages. It says nothing about this brand specifically.
Methodology →317
Methodology →317
TrialsTrialsClinicalTrials.gov studies for a fixed query about the MODALITY, not the brand. 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
Methodology →16
A 510(k) device is cleared, not approved — a different route, not a lesser one. What this measuresA 510(k) clearance means FDA agreed the device is substantially equivalent to a device already legally on the market. It is a clearance, not an approval: it is not a finding that the device is effective, and not a comparison against any other 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 →
Shares treatment areas — not a recommendation. What this measuresPicked mechanically, by rule and nothing else: products in the same Index category that share the most derived treatment areas with this one, ties broken alphabetically. Treatment areas are themselves derived by a published keyword rule run over a real source string, not copied from the cleared or approved indication, so a shared area means two products' source strings happened to use the same word. It does not mean the two products do the same job, it is not a claim that they are interchangeable, and it is not a recommendation.
Methodology →
Overview
- Modality
- Ultrasound lifting & tightening
- Manufacturer
- Sofwave Medical, Ltd.
- Category
- Body Contouring
- Latest decision
- FDA records
- 10
- Mapping
- Verified
Mapping is the weakest link on this page; the rule is published. What this measuresMatched 10 openFDA 510(k) record(s) whose device_name contains 'Sofwave' and whose applicant contains 'Sofwave'. A mapping is the weakest link on this page: if it is wrong, every number above it is about the wrong product. It is stated in full so it can be checked.
Methodology →
Regulatory
| Identifier | Type | Role | FDA record |
|---|---|---|---|
| K211483 | 510(k) — cleared | — | Open → |
| K223237 | 510(k) — cleared | — | Open → |
| K230019 | 510(k) — cleared | — | Open → |
| K230820 | 510(k) — cleared | — | Open → |
| K231537 | 510(k) — cleared | — | Open → |
| K232455 | 510(k) — cleared | — | Open → |
| K233104 | 510(k) — cleared | — | Open → |
| K240687 | 510(k) — cleared | — | Open → |
| K241685 | 510(k) — cleared | — | Open → |
| K250146 | 510(k) — cleared | Primary | Open → |
| Code | FDA device name | 21 CFR |
|---|---|---|
| NGX | Stimulator, Muscle, Powered, For Muscle Conditioning | 890.5850 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | 878.4590 |
Cleared indication: not transcribed here — read it on K250146 → Cleared indicationopenFDA's release of this database does not return the indications-for-use text, and this Index will not paraphrase a regulatory statement it has not transcribed. A 510(k) clearance means FDA agreed the device is substantially equivalent to a device already legally on the market. It is a clearance, not an approval: it is not a finding that the device is effective, and not a comparison against any other product.
Methodology →
EUDAMEDAlso registered in the EU
- Listed as
- Sofwave
- Manufacturer
- Sofwave Medical Ltd.
- Basic UDI-DI
- B-07290018152003
- UDI-DI
- 07290018152003
- Risk class
- Class IIa
- Status in EUDAMED
- On the market
Registered in EUDAMED, the EU device database. A registration, not an approval. What this measuresListed in EUDAMED, the EU medical device database, as of Jul 26 2026. EUDAMED registration became mandatory in May 2026 with a transition period, so devices not listed here may still be CE marked — we show only records we could match. A EUDAMED entry is a registration, not an FDA-style clearance or approval, and says nothing about safety, efficacy or quality. The name and manufacturer shown are spelled exactly as EUDAMED spells them.
Methodology →
Evidence
Counted for the modality, never the brand.
317PubMed, all time
261PubMed, 10y
16Studies
1Recruiting
| Ultrasound lifting & tightening | |
|---|---|
| 2016 | 20 |
| 2017 | 20 |
| 2018 | 19 |
| 2019 | 24 |
| 2020 | 27 |
| 2021 | 18 |
| 2022 | 19 |
| 2023 | 31 |
| 2024 | 37 |
| 2025 | 64 |
| 2026 | 25 |
64papers · 2025 · modality, not brand+73%
PubMed counts publications; ClinicalTrials.gov counts registrations. Neither is a quality score. What this measuresPubMed record counts and ClinicalTrials.gov study counts for a fixed query about the MODALITY, never 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 between modalities of different ages. It says nothing about this brand specifically. 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. The same counts apply to every other product in the Index on this modality: Ultherapy. The trend line is the same fixed modality query windowed per publication year. Number of PubMed records matching each modality's fixed, hand-written title/abstract query, windowed to a single publication year. It measures publication volume about a TECHNIQUE, not a brand. It is NOT a quality score, NOT an efficacy measure, and NOT a count of randomised trials. 2026 is a partial year (run date 2026-07-26); its bar is short because the year is short, not because interest fell. 2026 contains only papers indexed by the run date (2026-07-26). Render it visually distinct (e.g. hollow/hatched) or annotate it; never let it read as a decline.
Methodology →
PubMed query, verbatim
("microfocused ultrasound"[tiab] OR "micro-focused ultrasound"[tiab] OR "intense focused ultrasound"[tiab] OR ("ultrasound"[tiab] AND "skin tightening"[tiab]) OR ("ultrasound"[tiab] AND "skin laxity"[tiab])) AND (skin[tiab] OR face[tiab] OR facial[tiab] OR neck[tiab] OR cutaneous[tiab])
ClinicalTrials.gov query, verbatim
intervention: ("microfocused ultrasound" OR "micro-focused ultrasound" OR "intense focused ultrasound") condition: ("skin laxity" OR wrinkles OR "facial rejuvenation" OR skin OR cosmetic)
Treatment areas
What matched, and where
| Area | Matched term | Source string |
|---|---|---|
| Wrinkles & lines | wrinkle | ClinicalTrials.gov condition query for Ultrasound lifting & tightening |
| Skin laxity | skin laxity | ClinicalTrials.gov condition query for Ultrasound lifting & tightening |
| Photoaging & rejuvenation | rejuvenation | ClinicalTrials.gov condition query for Ultrasound lifting & tightening |
| Muscle stimulation | muscle conditioning | FDA product code NGX — Stimulator, Muscle, Powered, For Muscle Conditioning |
Derived by keyword rule, not the cleared or approved 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.
Methodology →
Sources
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=device_name:%22SofWave%22&sort=decision_date:desc&limit=100
- openFDA classification record for product code NGXhttps://api.fda.gov/device/classification.json?search=product_code:%22NGX%22&limit=1
- openFDA classification record for product code OHVhttps://api.fda.gov/device/classification.json?search=product_code:%22OHV%22&limit=1
- FDA public record for K250146https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K250146
- PubMed count, all timehttps://eutils.ncbi.nlm.nih.gov/entrez/eutils/esearch.fcgi?db=pubmed&retmode=json&rettype=count&term=%28%22microfocused%20ultrasound%22%5Btiab%5D%20OR%20%22micro-focused%20ultrasound%22%5Btiab%5D%20OR%20%22intense%20focused%20ultrasound%22%5Btiab%5D%20OR%20%28%22ultrasound%22%5Btiab%5D%20AND%20%22skin%20tightening%22%5Btiab%5D%29%20OR%20%28%22ultrasound%22%5Btiab%5D%20AND%20%22skin%20laxity%22%5Btiab%5D%29%29%20AND%20%28skin%5Btiab%5D%20OR%20face%5Btiab%5D%20OR%20facial%5Btiab%5D%20OR%20neck%5Btiab%5D%20OR%20cutaneous%5Btiab%5D%29
- PubMed count, last 10 yearshttps://eutils.ncbi.nlm.nih.gov/entrez/eutils/esearch.fcgi?db=pubmed&retmode=json&rettype=count&term=%28%22microfocused%20ultrasound%22%5Btiab%5D%20OR%20%22micro-focused%20ultrasound%22%5Btiab%5D%20OR%20%22intense%20focused%20ultrasound%22%5Btiab%5D%20OR%20%28%22ultrasound%22%5Btiab%5D%20AND%20%22skin%20tightening%22%5Btiab%5D%29%20OR%20%28%22ultrasound%22%5Btiab%5D%20AND%20%22skin%20laxity%22%5Btiab%5D%29%29%20AND%20%28skin%5Btiab%5D%20OR%20face%5Btiab%5D%20OR%20facial%5Btiab%5D%20OR%20neck%5Btiab%5D%20OR%20cutaneous%5Btiab%5D%29%20AND%20%28%222016%2F01%2F01%22%5Bdp%5D%20%3A%20%222026%2F12%2F31%22%5Bdp%5D%29
- ClinicalTrials.gov, all studieshttps://clinicaltrials.gov/api/v2/studies?query.intr=%28%22microfocused%20ultrasound%22%20OR%20%22micro-focused%20ultrasound%22%20OR%20%22intense%20focused%20ultrasound%22%29&query.cond=%28%22skin%20laxity%22%20OR%20wrinkles%20OR%20%22facial%20rejuvenation%22%20OR%20skin%20OR%20cosmetic%29&countTotal=true&pageSize=1&fields=NCTId
- ClinicalTrials.gov, recruiting onlyhttps://clinicaltrials.gov/api/v2/studies?query.intr=%28%22microfocused%20ultrasound%22%20OR%20%22micro-focused%20ultrasound%22%20OR%20%22intense%20focused%20ultrasound%22%29&query.cond=%28%22skin%20laxity%22%20OR%20wrinkles%20OR%20%22facial%20rejuvenation%22%20OR%20skin%20OR%20cosmetic%29&filter.overallStatus=RECRUITING&countTotal=true&pageSize=1&fields=NCTId
No adverse-event data is published anywhere on this site. What this measuresNo adverse-event data appears anywhere on this site. MAUDE and FAERS were never queried: those counts have no denominator, reporting is voluntary and duplicated, and a report is not evidence of causation. Publishing them beside a brand name would mislead.
Methodology →