510(k) Report

FDA applicant

Heraeus Lasersonics, Inc.

Milpitas, CA38 decisions1988–19940 recalls

FDA records 38 decisions for Heraeus Lasersonics, Inc. (Milpitas, CA) from 1988 to 1994: 38 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and HQF (Laser, Ophthalmic). 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 Heraeus Lasersonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Heraeus Lasersonics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Heraeus”

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