FDA applicant

Intra Lase Corp.

Irvine, CA9 decisions1999–20084 recalls

FDA records 9 decisions for Intra Lase Corp. (Irvine, CA) from 1999 to 2008: 9 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 17 predicates, 12 of them its own earlier devices. 4 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 Intra Lase Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2007high 1 (2007) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

3in 2011

2007high 3 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Intra Lase Corp.’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 “Intra”

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

Intra Luminal Therapeutics, Inc. 20 Intra-Lock International 13 Intra Vantage, Inc. 1 Intra Special Catheters GmbH 1 Intra-Sonix, Inc. 1 Intra-Optics Labs. C/O Newman Assoc. 1

Intra Lase Corp.

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 “Intra”