FDA applicant

Gamut Ent.

Snellville, GA1 decision1988–19880 recalls

FDA records 1 decision for Gamut Ent. (Snellville, GA) in 1988: 1 510(k) clearance. All are in product code HLR (Keratoscope, Battery-Powered). 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 Gamut Ent.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Gamut Ent. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Gamut Ent.’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

Gamut Ent.

Which product codes does it file in?

What has FDA decided for it lately?