510(k) Report

FDA applicant

Lasersight Technologies, Inc.

Winter Park, FL5 decisions1998–20000 recalls

FDA records 5 decisions for Lasersight Technologies, Inc. (Winter Park, FL) from 1998 to 2000: 3 510(k) clearances and 2 original PMA approvals. Most are in product codes HNO (Keratome, Ac-Powered) and LZS (Excimer Laser System). Its devices cite 6 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Lasersight Technologies, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Lasersight Technologies, 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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