MXG · Lamp, Uvc, (For Treating Skin And Wounds)
General, Plastic Surgery · 21 CFR 878.4630 · Class 2
Overview
| Product Code | MXG |
|---|---|
| Device Name | Lamp, Uvc, (For Treating Skin And Wounds) |
| Regulation | 21 CFR 878.4630 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.
Classification Rationale
Class II.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K973865 | BIRTCHER UV LAMP | Medfaxx, Inc. | Feb 26, 1999 | SESE |
Top Applicants
- Medfaxx, Inc. — 1 clearance
