Product areas
FDA product code distribution
Syneron-Candela
Country / Region:United States (US)Website:candelamedical.com
510(k) submissions
6
Filtered: GEX
Latest clearance
2018-07-11
Product codes
1
GEX
510(k) submissions
6 total · filtered by GEX
Showing 1–6
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K181523 | Syneron CO2RE System | GEX | Class 2 | 2018-07-11 |
| K180593 | Vbeam Prima Laser System | GEX | Class 2 | 2018-06-05 |
| K170597 | PicoWay Laser System | GEX | Class 2 | 2017-05-25 |
| K162454 | PicoWay Laser System | GEX | Class 2 | 2017-02-01 |
| K160607 | PicoWay Laser System | GEX | Class 2 | 2016-07-05 |
| K153527 | PicoWay Laser System | GEX | Class 2 | 2016-03-02 |
Company profile
- Canonical name
- Syneron-Candela
- Aliases
- Syneron-Candela Corp, Syneron Candela Corporation
- Country / Region
- United States(US)
- Website
- candelamedical.com
Predicate manufacturers
Companies whose devices this company cited as predicates
4 manufacturers
- 6
- 4
- 4
- 1
Citing manufacturers
Companies that cited this company's devices as predicates