Product areas
FDA product code distribution
Biolase, Inc.
Country / Region:United States (US)Website:biolase.com
510(k) submissions
8 total
Showing 1–8
| K number | Device name | Product code | Class | Decision |
|---|---|---|---|---|
| K210183 | Waterlase iPLus | GEX | Class 2 | 2022-04-21 |
| K193486 | Epic 980 | GEX | Class 2 | 2020-03-16 |
| K192430 | Epic 980 | GEX | Class 2 | 2019-12-04 |
| K190319 | Waterlase Laser System Family | GEX | Class 2 | 2019-10-10 |
| K172771 | Epic Pro 940 | GEX | Class 2 | 2017-11-29 |
| K163128 | Epic Pro | GEX | Class 2 | 2017-01-11 |
| K161669 | Waterlase Express | GEX | Class 2 | 2016-07-28 |
| K141975 | WATERLASE IPLUS S | GEX | Class 2 | 2015-03-05 |
Company profile
- Canonical name
- Biolase, Inc.
- Country / Region
- United States(US)
- Website
- biolase.com
Predicate manufacturers
Companies whose devices this company cited as predicates
3 manufacturers
- 5
- 1
- 1
Citing manufacturers
Companies that cited this company's devices as predicates
3 manufacturers
- 5
- 3
- 1