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., part of BiolaseLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Biolase, Inc. with 10 510(k) clearances. 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
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 |
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
