FDA applicant

Mentor Ophthalmics, Inc.

Norwell, MA4 decisions1996–19970 recalls

FDA records 4 decisions for Mentor Ophthalmics, Inc. (Norwell, MA) from 1996 to 1997: 4 510(k) clearances. Most are in product codes HKY (Tonometer, Manual) and KKX (Drape, Surgical, Antimicrobial). Its devices cite 1 predicate, 0 of them its own earlier devices. 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 Mentor Ophthalmics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Mentor Ophthalmics, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Mentor”

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

Mentor Corp. 67 Mentor O & O, Inc. 18 Mentor Worldwide, LLC 14 Mentor Medical Limited 1 Mentor Urology, Inc. 1

Mentor Ophthalmics, 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 “Mentor”