510(k) Report

FDA applicant

Endo Optics, Inc.

Marlboro, NJ2 decisions1993–19930 recalls

FDA records 2 decisions for Endo Optics, Inc. (Marlboro, NJ) in 1993: 2 510(k) clearances. Most are in product codes HQB (Photocoagulator And Accessories) and LRO (General Surgery Tray). 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 Endo Optics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Endo Optics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Endo Optics, 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 “Endo”

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