510(k) Report

FDA applicant

Photo Therapeutics Limited

Altrincham, Cheshire, GB7 decisions2003–20090 recalls

FDA records 7 decisions for Photo Therapeutics Limited (Altrincham, Cheshire, GB) from 2003 to 2009: 7 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and OHS (Light Based Over The Counter Wrinkle Reduction). Its devices cite 21 predicates, 8 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Photo Therapeutics, Inc.”.

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 Therapeutics Limited’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008: 12009: 1
2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

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Other applicant names beginning “Photo”

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