Biolase Technology, Inc.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Biolase Technology, Inc.” (first 1995, latest 2013), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 130 days. 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 |
|---|---|---|
| 2012 | 1 | 151 |
| 2013 | 3 | 269 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | 24 | 24 |
| MXF | System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation | 4 | 4 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| EFW | Toothbrush, Manual | 1 | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
Review panels
- General and Plastic Surgery (24)
- Dental (6)
- Physical Medicine (1)
Most recent Biolase Technology, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K122368 | WATERLASE IPLUS ALL TISSUE LASER | GEX | 2013-05-02 | 269 |
| K130465 | EPIC 10S | GEX | 2013-04-11 | 45 |
| K121327 | DIOLASE 10S | GEX | 2013-02-01 | 275 |
| K121286 | EPIC 10 | GEX | 2012-09-28 | 151 |
| K101658 | WATERLASE MD TURBO PLUS MODEL 7200XXX | GEX | 2010-08-11 | 61 |
| K093852 | EZLASE 3 LASER SYSTEM | GEX | 2010-03-12 | 86 |
| K091746 | WATERLASE MD, MODEL 7100102 | GEX | 2009-12-07 | 174 |
| K083927 | WATERLASE MD | GEX | 2009-10-01 | 274 |
| K091922 | WATERLASE C100, MODEL 7100104 | GEX | 2009-07-14 | 14 |
| K083595 | EZLASE | ILY | 2009-04-14 | 130 |
21 earlier clearances. See the full list in Caduvo.
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2014-06-12.
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.
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, Inc. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Biolase Technology, Inc.?
FDA lists 31 510(k) clearances under the applicant name “Biolase Technology, Inc.” (first 1995, latest 2013), across 5 product codes in 3 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 Technology, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Biolase Technology, Inc. is 130 days.
Which FDA product codes appear under Biolase Technology, Inc.?
The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 24); MXF (System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation, 4); EFB (Handpiece, Air-Powered, Dental, 1).
Next steps
- See all 31 Biolase Technology, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GEX, Biolase Technology, 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.