510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K935342Substantially Equivalent

Scmd Keratome

S.C.M.D. Keratomes of Arizona, Ftn. Hills AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K935342 is the FDA 510(k) clearance record for SCMD KERATOME, a class I device, cleared for S.C.M.D. Keratomes of Arizona on under FDA product code HNO (Keratome, Ac-Powered). FDA records list one 510(k) clearance for S.C.M.D. Keratomes of Arizona. As of , FDA records show no recalls naming K935342.

Clearance record

Decision date
Received
(147 days to decision)
Product code
HNO Keratome, Ac-Powered
Regulation
21 CFR 886.4370
Device class
Class I
Review panel
Ophthalmic
Applicant
S.C.M.D. Keratomes of Arizona 16833 E. Parlin Dr., Ftn. Hills AZ
510(k) summary
Statement
Third party review
No

Clearances, product code HNO

Trailing 12 months

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

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