510(k) Report

FDA applicant

Lasersafe, Inc.

Pittsburgh, PA3 decisions1985–19860 recalls

FDA records 3 decisions for Lasersafe, Inc. (Pittsburgh, PA) from 1985 to 1986: 3 510(k) clearances. Most are in product codes CAI (Circuit, Breathing (W Connector, Adaptor, Y…) and HOY (Shield, Eye, Ophthalmic (Including Sunlamp…). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Lasersafe, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lasersafe, 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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