Syneron Medical, Ltd.: FDA filings under this applicant name
FDA lists 35 510(k) clearances under the applicant name “Syneron Medical, Ltd.” (first 2002, latest 2017), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 99 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 78 |
| 2013 | 1 | 514 |
| 2014 | 3 | 171 |
| 2015 | 1 | 89 |
| 2016 | 3 | 107 |
| 2017 | 2 | 117 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Syneron Medical, Ltd. took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 20 | 20 |
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | 6 | 6 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 4 | 4 |
| NUV | Massager, Vacuum, Light Induced Heating | 4 | 4 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 1 | 1 |
Review panels
Most recent Syneron Medical, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170370 | ULTRASHAPE POWER SYSTEM | OHV | 2017-05-15 | 98 |
| K163415 | SlimShape System | GEI | 2017-04-20 | 136 |
| K162163 | UltraShape System | OHV | 2016-11-17 | 107 |
| K161952 | UltraShape System | OHV | 2016-11-07 | 115 |
| K160896 | ULTRASHAPE POWER SYSTEM | OHV | 2016-07-08 | 99 |
| K151655 | CO2RE System | GEX | 2015-09-15 | 89 |
| K141507 | TWO SKIN TREATMENT SYSTEM | GEI | 2014-12-08 | 185 |
| K141708 | ULTRASHAPE SYSTEM | OHV | 2014-10-06 | 104 |
| K133238 | CONTOUR I V3.1 SYSTEM | OHV | 2014-04-10 | 171 |
| K120510 | TRANSCEND | GEI | 2013-07-19 | 514 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Syneron Medical, Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Syneron Candela Corporation (7 510(k)s)
- Syneron Beauty (2 510(k)s)
- Syneron Beauty , Ltd. (2 510(k)s)
- Syneron, Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Syneron Medical, Ltd.?
FDA lists 35 510(k) clearances under the applicant name “Syneron Medical, Ltd.” (first 2002, latest 2017), across 5 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Syneron Medical, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Syneron Medical, Ltd. is 99 days.
Which FDA product codes appear under Syneron Medical, Ltd.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 20); OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption, 6); GEI (Electrosurgical, Cutting & Coagulation & Accessories, 4).
Next steps
- See all 35 Syneron Medical, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Syneron Medical, Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.