510(k) Report

FDA applicant

Cooper Lasersonics, Inc.

Santa Clara, CA54 decisions1982–19880 recalls

FDA records 54 decisions for Cooper Lasersonics, Inc. (Santa Clara, CA) from 1982 to 1988: 54 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and LNK (Laser For Gastro-Urology Use). 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 Cooper Lasersonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Cooper Lasersonics, Inc.’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 “Cooper”

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