MUW · Lens, Contact (Orthokeratology)
Ophthalmic · 21 CFR 886.5916 · Class 2
Overview
| Product Code | MUW |
|---|---|
| Device Name | Lens, Contact (Orthokeratology) |
| Regulation | 21 CFR 886.5916 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.
Classification Rationale
(1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K183200 | iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses | C&E GP Specialist, Inc. | Jan 9, 2019 | SESE |
| K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | Contamac, Ltd. | Jul 13, 2016 | SESE |
| K010109 | FLUOROPERM 151-OK, PARAGON HDS 100-OK | Paragon Vision Sciences | Feb 28, 2001 | SESU |
| K003933 | BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY | Polymer Technology | Feb 16, 2001 | SESE |
| K000224 | FLUROPERM 60-OK, PARAGON HDS-OK | Paragon Vision Sciences | Apr 17, 2000 | SESU |
| K973697 | AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY | Airperm, Inc. | Apr 8, 1998 | SESE |
Top Applicants
- Paragon Vision Sciences — 2 clearances
- Airperm, Inc. — 1 clearance
- C&E GP Specialist, Inc. — 1 clearance
- Contamac, Ltd. — 1 clearance
- Polymer Technology — 1 clearance
