Company ยท US
Biolase, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2014 to 2022. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 21, 2022 | K210183 | Waterlase iPLus Biolase, Inc. | GEX |
| Dec 22, 2021 | K213428 | EdgePro Biolase, Inc. | NVK |
| Mar 16, 2020 | K193486 | Epic 980 Biolase, Inc. | GEX |
| Dec 4, 2019 | K192430 | Epic 980 Biolase, Inc. | GEX |
| Oct 10, 2019 | K190319 | Waterlase Laser System Family Biolase, Inc. | GEX |
| Nov 29, 2017 | K172771 | Epic Pro 940 Biolase, Inc. | GEX |
| Jan 11, 2017 | K163128 | Epic Pro Biolase, Inc. | GEX |
| Jul 28, 2016 | K161669 | Waterlase Express Biolase, Inc. | GEX |
| Mar 5, 2015 | K141975 | WATERLASE IPLUS S Biolase, Inc. | GEX |
| Oct 10, 2014 | K140120 | EPIC 10 Biolase, Inc. | GEX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||