NUU · Lens, Contact, Orthokeratology, Overnight
Ophthalmic · 21 CFR 886.5916 · Class 3
Overview
| Product Code | NUU |
|---|---|
| Device Name | Lens, Contact, Orthokeratology, Overnight |
| Regulation | 21 CFR 886.5916 |
| Device Class | Class 3 |
| 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.
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P240045 | Optimum Infinite (tisilfocon A) Orthokeratology Lenses II | Contamac, Ltd. | Feb 10, 2026 | APPR |
| P050031 | PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY | CooperVision, Inc. | Nov 16, 2006 | APPR |
| P040029 | Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact | Euclid Vision Corporation | Sep 29, 2004 | APPR |
| P010062 | EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENS FOR OVERNIGHT WEAR | Bausch & Lomb | Jun 7, 2004 | APPR |
Top Applicants
- Euclid Vision Corporation — 1 clearance
- CooperVision, Inc. — 1 clearance
- Contamac, Ltd. — 1 clearance
- Bausch & Lomb — 1 clearance
