FDA applicant

Refractec, Inc.

Laguna Hills, CA3 decisions1998–20060 recalls

FDA records 3 decisions for Refractec, Inc. (Laguna Hills, CA) from 1998 to 2006: 2 510(k) clearances and 1 original PMA approval. Most are in product codes HQR (Apparatus, Cautery, Radiofrequency, Ac-Powered) and HMR (Marker, Ocular). 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 Refractec, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Refractec, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Refractec, Inc.

Which product codes does it file in?

What has FDA decided for it lately?