510(k) Report

FDA applicant

Opti-Centre Laboratories

Grand Junction, CO6 decisions1998–20050 recalls

FDA records 6 decisions for Opti-Centre Laboratories (Grand Junction, CO) from 1998 to 2005: 6 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 3 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 Opti-Centre Laboratories’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Opti-Centre Laboratories since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Opti-Centre”

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