1 Series Phototherapy Equipment
Device Facts
| Record ID | K220840 |
|---|---|
| Device Name | 1 Series Phototherapy Equipment |
| Applicant | Daavlin Distributing Co. |
| Product Code | FTC · General, Plastic Surgery |
| Decision Date | Apr 22, 2022 |
| Decision | SESE |
| Submission Type | Special |
| 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.
