510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K973697Substantially Equivalent

Airperm (Siflufocon a) Rigid Gas Permeable Ok Contact Lenses for Daily Wear Orthokeratology

Airperm, Inc., Sherman Oaks CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K973697 is the FDA 510(k) clearance record for AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY, a class II device, cleared for Airperm, Inc. on under FDA product code MUW (Lens, Contact (Orthokeratology)). FDA records list 3 510(k) clearances for Airperm, Inc., from to . As of , FDA records show no recalls naming K973697.

Clearance record

Decision date
Received
(194 days to decision)
Product code
MUW Lens, Contact (Orthokeratology)
Regulation
21 CFR 886.5916
Device class
Class II
Review panel
Ophthalmic
Applicant
Airperm, Inc. 4505 Van Nuys Blvd., Sherman Oaks CA
510(k) summary
Summary
Third party review
No

Clearances, product code MUW

Trailing 12 months

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

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