FDA applicant

Photo Medex, Inc.

Carlsbad, CA10 decisions2001–20081 recall

FDA records 10 decisions for Photo Medex, Inc. (Carlsbad, CA) from 2001 to 2008: 10 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 43 predicates, 15 of them its own earlier devices. 1 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 Photo Medex, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2008

2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Photo Medex, 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 “Photo”

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

Photo Therapeutics Limited 7 Photo Medic Equipment, Inc. 1

Photo Medex, 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 “Photo”