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510(k) K973697

AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY by Airperm, Inc. — Product Code MUW

K973697 is an FDA 510(k) premarket notification submitted by Airperm, Inc. for the device "AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY". The FDA issued a decision of Substantially Equivalent on April 8, 1998. The device falls under product code MUW (Lens, Contact (Orthokeratology)), a Class II device regulated under 21 CFR 886.5916. Airperm, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 1998
Date Received
September 26, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact (Orthokeratology)
Device Class
Class II
Regulation Number
886.5916
Review Panel
OP
Submission Type

Other clearances by Airperm, Inc.

  • K962934 — AIRPERM(SIFLUFOCON A) RIGID GAS PERMEABLE MULTIFOCAL CONTACT LENSES FOR DAILY WE (August 27, 1996)
  • K941883 — CONTACT LENS (October 28, 1994)

Other clearances for product code MUW

  • K183200 — iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses (January 9, 2019)
  • K160859 — OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (July 13, 2016)
  • K010109 — FLUOROPERM 151-OK, PARAGON HDS 100-OK (February 28, 2001)
  • K003933 — BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY (February 16, 2001)
  • K000224 — FLUROPERM 60-OK, PARAGON HDS-OK (April 17, 2000)

FDA data resources