510(k) Report

FDA applicant

Coherent Star

Pleasanton, CA2 decisions2000–20012 recalls

FDA records 2 decisions for Coherent Star (Pleasanton, CA) from 2000 to 2001: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). 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 Coherent Star’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Coherent Star since 2007.

Recalls per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

Class I Class II/III not classified

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

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Other applicant names beginning “Coherent”

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