510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964312Substantially Equivalent

Mentor Tono-Pen 3

Mentor Ophthalmics, Inc., Norwell MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964312 is the FDA 510(k) clearance record for MENTOR TONO-PEN 3, a class II device, cleared for Mentor Ophthalmics, Inc. on under FDA product code HKY (Tonometer, Manual). FDA records list 4 510(k) clearances for Mentor Ophthalmics, Inc., from to . As of , FDA records show no recalls naming K964312.

Clearance record

Decision date
Received
(28 days to decision)
Product code
HKY Tonometer, Manual
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Mentor Ophthalmics, Inc. 3000 Longwater Dr., Norwell MA
510(k) summary
Summary
Third party review
No

Clearances, product code HKY

Trailing 12 months

FDA records hold no clearances under product code HKY in the trailing twelve months.

FDA records show no clearances under product code HKY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HKY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260