Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biolase, Inc. — Predicate Candidate Screening
10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
451 days90th percentile
10clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K210183 | Waterlase iPLus | Biolase, Inc. | 2022-04-21 | 451 | 0 |
| K213428 | EdgePro | Biolase, Inc. | 2021-12-22 | 62 | 0 |
| K193486 | Epic 980 | Biolase, Inc. | 2020-03-16 | 90 | 0 |
| K192430 | Epic 980 | Biolase, Inc. | 2019-12-04 | 90 | 0 |
| K190319 | Waterlase Laser System Family | Biolase, Inc. | 2019-10-10 | 239 | 0 |
| K172771 | Epic Pro 940 | Biolase, Inc. | 2017-11-29 | 76 | 0 |
| K163128 | Epic Pro | Biolase, Inc. | 2017-01-11 | 64 | 0 |
| K161669 | Waterlase Express | Biolase, Inc. | 2016-07-28 | 42 | 0 |
| K141975 | WATERLASE IPLUS S | Biolase, Inc. | 2015-03-05 | 227 | 0 |
| K140120 | EPIC 10 | Biolase, Inc. | 2014-10-10 | 267 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda