510(k) Report

FDA applicant

Adept Medical Concepts

Rancho Santa Margarita, CA4 decisions2003–20040 recalls

FDA records 4 decisions for Adept Medical Concepts (Rancho Santa Margarita, CA) from 2003 to 2004: 4 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 45 predicates, 0 of them its own earlier devices. No 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 Adept Medical Concepts’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Adept Medical Concepts since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Adept”

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