510(k) Report

FDA applicant

Biocompatibles Eyewear, Inc.

Norfolk, VA3 decisions1997–19980 recalls

FDA records 3 decisions for Biocompatibles Eyewear, Inc. (Norfolk, VA) from 1997 to 1998: 3 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 1 predicate, 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 Biocompatibles Eyewear, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Biocompatibles Eyewear, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Biocompatibles Eyewear, 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 “Biocompatibles”

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