FDA applicant

Tony Optical Enterprises Co., Ltd.

Nei Hu District, Taipei, 11401, TW1 decision1995–19950 recalls

FDA records 1 decision for Tony Optical Enterprises Co., Ltd. (Nei Hu District, Taipei, 11401, TW) in 1995: 1 510(k) clearance. All are in product code 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 Tony Optical Enterprises Co., Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Tony Optical Enterprises Co., Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Tony Optical Enterprises Co., 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 “Tony”

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

Tony (U.S.A.), Inc. 1 Tony Riso Co., Inc. 1

Tony Optical Enterprises Co., Ltd.

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Tony”