Biolase, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Biolase, Inc.” (first 2014, latest 2022), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 90 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2014 | 1 | 267 |
| 2015 | 1 | 227 |
| 2016 | 1 | 42 |
| 2017 | 2 | 70 |
| 2018 | 0 | — |
| 2019 | 2 | 164 |
| 2020 | 1 | 90 |
| 2021 | 1 | 62 |
| 2022 | 1 | 451 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Biolase, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 9 | 9 |
| NVK | Laser, Dental, Soft Tissue | 1 | 1 |
Review panels
Most recent Biolase, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210183 | Waterlase iPLus | GEX | 2022-04-21 | 451 |
| K213428 | EdgePro | NVK | 2021-12-22 | 62 |
| K193486 | Epic 980 | GEX | 2020-03-16 | 90 |
| K192430 | Epic 980 | GEX | 2019-12-04 | 90 |
| K190319 | Waterlase Laser System Family | GEX | 2019-10-10 | 239 |
| K172771 | Epic Pro 940 | GEX | 2017-11-29 | 76 |
| K163128 | Epic Pro | GEX | 2017-01-11 | 64 |
| K161669 | Waterlase Express | GEX | 2016-07-28 | 42 |
| K141975 | WATERLASE IPLUS S | GEX | 2015-03-05 | 227 |
| K140120 | EPIC 10 | GEX | 2014-10-10 | 267 |
Recalls
openFDA lists no recalls under a recalling firm named Biolase, Inc..
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.
Device clinical trials
An industry sponsor named Biolase, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT05276817: Perio. Maint. With Diode LBR (Completed, started 2022-04-01)
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.
- Biolase Technology, Inc. (31 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biolase, Inc.?
FDA lists 10 510(k) clearances under the applicant name “Biolase, Inc.” (first 2014, latest 2022), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Biolase, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biolase, Inc. is 90 days. Since 2017: 90 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Biolase, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 9); NVK (Laser, Dental, Soft Tissue, 1).
Next steps
- See all 10 Biolase, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Biolase, Inc.'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.