510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K903666Substantially Equivalent

Ophthasonic A/p III

Teknar, Inc., Fenton MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903666 is the FDA 510(k) clearance record for OPHTHASONIC A/P III, a class I device, cleared for Teknar, Inc. on under FDA product code HPY (Unit, Electrolysis, Battery-Powered, Ophthalmic). FDA records list 18 510(k) clearances for Teknar, Inc., from to . As of , FDA records show no recalls naming K903666.

Clearance record

Decision date
Received
(97 days to decision)
Product code
HPY Unit, Electrolysis, Battery-Powered, Ophthalmic
Regulation
21 CFR 886.4250
Device class
Class I
Review panel
Ophthalmic
Applicant
Teknar, Inc. 267 Wolfner Dr., Fenton MO
Third party review
No

Clearances, product code HPY

Trailing 12 months

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

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