Syneron Candela Corporation: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Syneron Candela Corporation” (first 2016, latest 2017), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 125 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 |
|---|---|---|
| 2016 | 3 | 125 |
| 2017 | 2 | 120 |
| 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 Candela Corporation took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 4 | 4 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 | 1 |
Review panels
Most recent Syneron Candela Corporation 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170597 | PicoWay Laser System | GEX | 2017-05-25 | 86 |
| K162454 | PicoWay Laser System | GEX | 2017-02-01 | 153 |
| K161043 | Profound System | PBX | 2016-09-12 | 152 |
| K160607 | PicoWay Laser System | GEX | 2016-07-05 | 125 |
| K153527 | PicoWay Laser System | GEX | 2016-03-02 | 84 |
Recalls
openFDA lists no recalls under a recalling firm named Syneron Candela Corporation.
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 Medical, Ltd. (35 510(k)s)
- Syneron Beauty , Ltd. (4 510(k)s)
- Syneron, Ltd. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Syneron Candela Corporation?
FDA lists 5 510(k) clearances under the applicant name “Syneron Candela Corporation” (first 2016, latest 2017), across 2 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 Candela Corporation?
The median time from FDA receipt to decision across 510(k)s cleared under the name Syneron Candela Corporation is 125 days.
Which FDA product codes appear under Syneron Candela Corporation?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 4); PBX (Massager, Vacuum, Radio Frequency Induced Heat, 1).
Next steps
- See all 5 Syneron Candela Corporation clearances with predicates and recalls
- Run predicate analysis for product code GEX, Syneron Candela Corporation'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.