# K973697: Airperm (Siflufocon a) Rigid Gas Permeable OK Contact Lenses for Daily Wear Orthokeratology

- Pathway: 510(k) (Traditional)
- Applicant: Airperm, Inc.
- Decided: Apr 8, 1998 after 194 days
- Product code: MUW (Lens, Contact (Orthokeratology))
- Device class: 2
- Regulation: 21 CFR 886.5916
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) predicate lens of rigid contact lens material: named in the summary without a submission number

## Most influential descendants
- K160859: OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (2016), 0 descendants of its own

## Indications for use
The CONTEX OK™ (siflufocon A) Rigid Gas Permeable Contact Lens for Orthokeratology is indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lens is indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 3.00 diopters. The lens may be disinfected using a chemical disinfection system only. Note: To maintain the orthokeratology effect of myopia reduction lens wear must be continued on a prescribed wearing schedule.

Source page: https://510kreport.com/device/K973697
Methodology: https://510kreport.com/methodology