KGL · Cabinet, Phototherapy (Puva)
General, Plastic Surgery · 21 CFR 878.4630 · Class 2
Overview
| Product Code | KGL |
|---|---|
| Device Name | Cabinet, Phototherapy (Puva) |
| 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 (8 of 8)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K852575 | WALDMANN F85/100W PUVA | Sylvania Lighting Products | Aug 16, 1985 | SESD |
| K841795 | UV 8001K, PUVA 800, PUVA 180/200 1000 | Waldmann Lighting Co. | Aug 30, 1984 | SESE |
| K820280 | SPECTRA 305/350 | Ultralite | Mar 5, 1982 | SESE |
| K810668 | HO-B-LITE VI UNIT | National Biological Corp. | Apr 23, 1981 | SESE |
| K810358 | PHOTOTHERAPY LIGHT CHAMBER | Paul B. Elder Co. | Mar 20, 1981 | SESE |
| K791977 | PSORALITE MARK I | Paul B. Elder Co. | Dec 28, 1979 | SESE |
| K791116 | PSORALITE SERIES 30,000 | Paul B. Elder Co. | Sep 4, 1979 | SESE |
| K761094 | UVA PHOTOTHERAPY SYSTEM | Dermatron Corp. | Dec 2, 1976 | SESE |
Top Applicants
- Paul B. Elder Co. — 3 clearances
- Waldmann Lighting Co. — 1 clearance
- Ultralite — 1 clearance
- Sylvania Lighting Products — 1 clearance
- National Biological Corp. — 1 clearance
