DERMACLEAR UV-B PHOTOTHERAPY SYSTEM
Device Facts
| Record ID | K011197 |
|---|---|
| Device Name | DERMACLEAR UV-B PHOTOTHERAPY SYSTEM |
| Applicant | Lumenis |
| Product Code | FTC · General, Plastic Surgery |
| Decision Date | Dec 14, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4630 |
| Device Class | Class 2 |
Regulatory Classification
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.
