FDA applicant

Copper Lasersonics, Inc.

Santa Clara, CA1 decision1988–19880 recalls

FDA records 1 decision for Copper Lasersonics, Inc. (Santa Clara, CA) in 1988: 1 510(k) clearance. All are in product code HHR (Laser, Surgical, Gynecologic). 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, obstetrics and gynecology panel, where it files most

How often FDA has decided Copper Lasersonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

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

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Copper Lasersonics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?