FDA applicant

Synergeyes, Inc.

Rockville, MD11 decisions2005–20160 recalls

FDA records 11 decisions for Synergeyes, Inc. (Rockville, MD) from 2005 to 2016: 11 510(k) clearances. All are in product code HQD (Lens, Contact (Other Material) - Daily). Its devices cite 24 predicates, 9 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Synergeyes”.

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 Synergeyes, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2016

2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Synergeyes, 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

Synergeyes, Inc.

Which product codes does it file in?

Whose devices does it build on?

Which of its devices are cited most?

What has FDA decided for it lately?