Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Biolase and its 1 subsidiaries with 41 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Apr 21, 2022: Waterlase iPLus.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Biolase and its 1 subsidiaries
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Apr 21, 2022 | Waterlase iPLusK210183 · GEX | 510(k) clearances |
| Dec 22, 2021 | EdgeProK213428 · NVK | 510(k) clearances |
| Mar 16, 2020 | Epic 980K193486 · GEX | 510(k) clearances |
| Dec 4, 2019 | Epic 980K192430 · GEX | 510(k) clearances |
| Oct 10, 2019 | Waterlase Laser System FamilyK190319 · GEX | 510(k) clearances |
| Nov 29, 2017 | Epic Pro 940K172771 · GEX | 510(k) clearances |
| Jan 11, 2017 | Epic ProK163128 · GEX | 510(k) clearances |
| Jul 28, 2016 | Waterlase ExpressK161669 · GEX | 510(k) clearances |
| Jun 12, 2014 | WaterLase iPlus Dental Laser System, Part No. 7200854-XX Software Upgrade Kit, Part No. 6201463.Class II · Biolase is recalling the WaterLase iPlus Dental Laser System because of a discrepancy present in the user interface soft | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
