FDA applicant

Biolase, Inc.

Irvine, CA10 decisions2014–20220 recalls

FDA records 10 decisions for Biolase, Inc. (Irvine, CA) from 2014 to 2022: 10 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and NVK (Laser, Dental, Soft Tissue). Since 2016 its 510(k)s took a median of 83 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 20 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, general and plastic surgery panel, where it files most

How often FDA has decided Biolase, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2014high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2014.

FIG. 1 — Biolase, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biolase, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Biolase”

FDA records each applicant name separately; these may or may not be the same firm.

Biolase Technology, Inc. 31

Biolase, Inc.

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Biolase”