FDA applicant

Neolens, Inc.

Miami, FL2 decisions1988–19880 recalls

FDA records 2 decisions for Neolens, Inc. (Miami, FL) in 1988: 2 510(k) clearances. Most are in product codes HQG (Lens, Spectacle, Non-Custom (Prescription)) and HQY (Sunglasses (Non-Prescription Including…). 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 Neolens, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Neolens, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Neolens, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Neolens, Inc.

Which product codes does it file in?

What has FDA decided for it lately?