510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801418Substantially Equivalent

Keeler Amoils Acull Cryo Ophthalmic Unit

Keeler Optical Products, Ltd., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K801418 is the FDA 510(k) clearance record for KEELER AMOILS ACULL CRYO OPHTHALMIC UNIT, a class II device, cleared for Keeler Optical Products , Ltd. on under FDA product code HPS (Unit, Cryophthalmic). FDA records list 5 510(k) clearances for Keeler Optical Products , Ltd., from to . As of , FDA records show no recalls naming K801418.

Clearance record

Decision date
Received
(34 days to decision)
Product code
HPS Unit, Cryophthalmic
Regulation
21 CFR 886.4170
Device class
Class II
Review panel
Ophthalmic
Applicant
Keeler Optical Products , Ltd. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HPS

Trailing 12 months

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

FDA records show no clearances under product code HPS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HPS, 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