FDA applicant

Hoya Photonics, Inc.

Fremont, CA5 decisions2004–20101 recall

FDA records 5 decisions for Hoya Photonics, Inc. (Fremont, CA) from 2004 to 2010: 5 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 1 predicate, 0 of them its own earlier devices. 1 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, general and plastic surgery panel, where it files most

How often FDA has decided Hoya Photonics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2010) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2013

2007high 1 (2013) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Hoya Photonics, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Hoya”

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

Hoya Conbio, Inc. 8 Hoya Surgical Optics, Inc. 2 Hoya Lamphun, Ltd. 2 Hoya Corporation 1 Hoya Corp. USA 1

Hoya Photonics, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

What has been recalled?

Other applicant names beginning “Hoya”