Alma Lasers, Inc.
510(k) · clearedClass IIK101147EU
Cleared2007Studies255Trials0
UltraShape — FDA clearance record and published evidence
Syneron Medical, Ltd. · Body Contouring
510(k) · clearedClass IIK170370
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 cleared2014
Years on marketYears on marketDerived: the data run date minus the first matched FDA decision date. Arithmetic on a real date, nothing else.
Methodology →12
Methodology →12
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 →—
Methodology →—
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 →—
Methodology →—
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 →
Overview
- Modality
- —
- Manufacturer
- Syneron Medical, Ltd.
- Category
- Body Contouring
- Latest decision
- FDA records
- 5
- Mapping
- Verified
Mapping is the weakest link on this page; the rule is published. What this measuresFive records whose device_name contains 'ULTRASHAPE', applicant Syneron Medical, Ltd., product code OHV. MODALITY LEFT NULL ON PURPOSE: the only existing ultrasound modality is ultrasound-skin-tightening, whose PubMed query is written around microfocused ultrasound for skin laxity. UltraShape destroys adipocytes and belongs to a fat-reduction modality that does not exist yet. 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 |
|---|---|---|---|
| K141708 | 510(k) — cleared | — | Open → |
| K160896 | 510(k) — cleared | — | Open → |
| K161952 | 510(k) — cleared | — | Open → |
| K162163 | 510(k) — cleared | — | Open → |
| K170370 | 510(k) — cleared | Primary | Open → |
| Code | FDA device name | 21 CFR |
|---|---|---|
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | 878.4590 |
Cleared indication: not transcribed here — read it on K170370 → 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 →
Evidence
No modality is assigned to this product, so no literature or trial counts are shown.
Treatment areas
No treatment area could be derived: neither the modality's condition query nor the FDA product codes contained a term on the keyword list.
Sources
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=device_name:%22UltraShape%22&sort=decision_date:desc&limit=100
- openFDA query run for this producthttps://api.fda.gov/device/510k.json?search=applicant:%22Syneron%22&sort=decision_date:desc&limit=100
- openFDA classification record for product code OHVhttps://api.fda.gov/device/classification.json?search=product_code:%22OHV%22&limit=1
- FDA public record for K170370https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K170370
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 →