PHOTOTHERAPEUTIX MODEL 800B
Device Facts
| Record ID | K933952 |
|---|---|
| Device Name | PHOTOTHERAPEUTIX MODEL 800B |
| Applicant | Avex Industries , Ltd. |
| Product Code | FTC · General, Plastic Surgery |
| Decision Date | Feb 21, 1995 |
| 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.
