510(k) Report

FDA applicant

Optical Integrity, Inc.

Panama City Beach, FL2 decisions2002–20100 recalls

FDA records 2 decisions for Optical Integrity, Inc. (Panama City Beach, FL) from 2002 to 2010: 2 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 6 predicates, 1 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2010

2010: 1
2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Optical Integrity, 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 “Optical”

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