Cleared Traditional

AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY

K973697 · Airperm, Inc. · Ophthalmic

Apr 1998

Decision

194d

Days

Class 2

Risk

About This 510(k) Submission

K973697 is an FDA 510(k) clearance for the AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY, a Lens, Contact (orthokeratology) (Class II — Special Controls, product code MUW), submitted by Airperm, Inc. (Sherman Oaks, US). The FDA issued a Cleared decision on April 8, 1998, 194 days after receiving the submission on September 26, 1997. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number	K973697 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 26, 1997
Decision Date	April 08, 1998
Days to Decision	194 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF