MZD · System, In-Office Tinting, Contact Lenses
Ophthalmic · 21 CFR 886.5925 · Class 2
Overview
| Product Code | MZD |
|---|---|
| Device Name | System, In-Office Tinting, Contact Lenses |
| Regulation | 21 CFR 886.5925 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K991995 | SOFTCHROME TINTS, TRANSPARENT TINTED SOFT CONTACT LENS | Softchrome, Inc. | Aug 27, 1999 | SESE |
Top Applicants
- Softchrome, Inc. — 1 clearance
