# K160859: OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)

- Pathway: 510(k) (Traditional)
- Applicant: Contamac, Ltd.
- Decided: Jul 13, 2016 after 106 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
Longest line of descent: 5 generations back to K943177 (1994). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K033594: Optimum GP (Oxygen Permeable) Daily Wear Contact Lenses, Contamac, Ltd. (2004) Summary page 5.
- K973697: Airperm (Siflufocon a) Rigid Gas Permeable OK Contact Lenses for Daily Wear Orthokeratology, Airperm, Inc. (1998) Summary page 5.
- K071266: Boston X02 (Hexafocon B) Rigid Gas Permeable Contact Lens, Bausch & Lomb, Inc. (2007) Summary page 5.

## Indications for use
The OPTIMUM GP OK contact lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Source page: https://510kreport.com/device/K160859
Methodology: https://510kreport.com/methodology