FDA applicant

Hoya Conbio, Inc.

Twain Harte, CA8 decisions2004–20090 recalls

FDA records 8 decisions for Hoya Conbio, Inc. (Twain Harte, CA) from 2004 to 2009: 8 510(k) clearances. All are in product code GEX (Powered Laser Surgical Instrument). Its devices cite 23 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Hoya Conbio”.

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

FDA decisions per year

1in 2009

2007high 2 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Hoya Conbio, 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

Other applicant names beginning “Hoya”

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

Hoya Photonics, Inc. 5 Hoya Surgical Optics, Inc. 2 Hoya Lamphun, Ltd. 2 Hoya Corporation 1 Hoya Corp. USA 1

Hoya Conbio, 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?

Other applicant names beginning “Hoya”