FDA applicant

Silhouette Optical, Ltd.

Northvale, NJ2 decisions1994–19950 recalls

FDA records 2 decisions for Silhouette Optical, Ltd. (Northvale, NJ) from 1994 to 1995: 2 510(k) clearances. Most are in product codes HQY (Sunglasses (Non-Prescription Including…) and HQZ (Frame, Spectacle). 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 Silhouette Optical, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Silhouette Optical, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Silhouette”

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

Silhouette Lift, Inc. 5

Silhouette Optical, Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Silhouette”