MWL · Lens, Contact (Rigid Gas Permeable), Extended Wear
Ophthalmic · 21 CFR 886.5916 · Class 3
Overview
| Product Code | MWL |
|---|---|
| Device Name | Lens, Contact (Rigid Gas Permeable), Extended Wear |
| 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.
Recent Cleared Devices (6 of 6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P990018 | MENICON Z RIGID GAS PERMEABLE CONTACT LENS | Menicon Co, Ltd. | Jul 11, 2000 | APPR |
| P880098 | MENICON SF-P RGP (MELAFOCON A) CONTACT LENS | Menicon Co, Ltd. | Sep 1, 1989 | APWD |
| P890020 | FLUOROCON TM-60 | Ciba Vision Corporation | Jun 23, 1989 | APWD |
| P870024 | FLUOROPERM RGP CONTACT LENSES | CooperVision, Inc. | Dec 31, 1987 | APPR |
| P860022 | BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS | Bausch & Lomb | Nov 30, 1987 | APPR |
| P850038 | PARAPERM E.W. BLUE RIGID GAS PERMEABLE CONTACT LEN | Paragon Optical Co. | Dec 31, 1986 | APWD |
Top Applicants
- Menicon Co, Ltd. — 2 clearances
- Bausch & Lomb — 1 clearance
- Ciba Vision Corporation — 1 clearance
- CooperVision, Inc. — 1 clearance
- Paragon Optical Co. — 1 clearance
