Product areas
FDA product code distribution
Candela Corporation
Country / Region:United States (US)Website:candela.com
510(k) submissions
7
Filtered: GEX
Latest clearance
2023-06-01
Product codes
1
GEX
510(k) submissions
7 total · filtered by GEX
Showing 1–7
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K230990 | Candela Vbeam Family of Pulsed Dye Lasers (Vbeam Prima, Vbeam Perfecta) | GEX | Class 2 | 2023-06-01 |
| K220853 | PicoWay Laser System | GEX | Class 2 | 2022-10-13 |
| K212492 | Frax 1940 for Nordlys and Frax Pro | GEX | Class 2 | 2021-12-20 |
| K201111 | GentleMax Pro Plus | GEX | Class 2 | 2020-05-26 |
| K191685 | PicoWay Laser System | GEX | Class 2 | 2019-09-16 |
| K183452 | Vbeam Prima Laser System | GEX | Class 2 | 2019-02-01 |
| K150326 | PicoWay Laser System | GEX | Class 2 | 2015-04-16 |
Company profile
- Canonical name
- Candela Corporation
- Aliases
- Candela Corp.
- Country / Region
- United States(US)
- Website
- candela.com
Predicate manufacturers
Companies whose devices this company cited as predicates
5 manufacturers
- 5
- 3
- 1
- 1
- 1
Citing manufacturers
Companies that cited this company's devices as predicates
16 manufacturers
- 4
- 3
- 2
- 1
- 1
- 1
- 1
- 1
- 1
- 1
- 1
- 1
- 1
- 1
- 1
- 1