FDA applicant

Biolase Technology, Inc.

Irvine, CA31 decisions1995–20132 recalls

FDA records 31 decisions for Biolase Technology, Inc. (Irvine, CA) from 1995 to 2013: 31 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and MXF (System, Dental, Hydrokinetic, Caries Removal &…). Its devices cite 75 predicates, 35 of them its own earlier devices. 2 recalls are 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 Technology, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

3in 2013

2007high 5 (2008) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

1in 2014

2007high 1 (2014) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Biolase Technology, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Biolase Technology, 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, Inc. 10

Biolase Technology, Inc.

Which product codes does it file in?

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?

What has been recalled?

Other applicant names beginning “Biolase”