Cabinet, Phototherapy (Puva)
PUVA Phototherapy Cabinet is a device that emits ultraviolet A (UVA) radiation, used in dermatology in conjunction with a photosensitizing drug (psoralen) to treat psoriasis, vitiligo, mycosis fungoides, and other skin conditions through psoralen-UVA photochemotherapy. It is classified as FDA Class 2, indicating moderate risk; devices in this category are subject to general controls and special controls, and typically require 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is KGL, regulated under 21 CFR 878.4630, within the General, Plastic Surgery medical specialty. This device is eligible for third-party review.
Research product code KGL in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- KGL
- Device Class
- FDA class 2
- Regulation Number
- 878.4630
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- SU
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K852575 | WALDMANN F85/100W PUVA | Aug 16, 1985 | Unknown | Sylvania Lighting Products |
| K841795 | UV 8001K, PUVA 800, PUVA 180/200 1000 | Aug 30, 1984 | Substantially Equivalent | Waldmann Lighting Co. |
| K820280 | SPECTRA 305/350 | Mar 05, 1982 | Substantially Equivalent | Ultralite |
| K810668 | HO-B-LITE VI UNIT | Apr 23, 1981 | Substantially Equivalent | National Biological Corp. |
| K810358 | PHOTOTHERAPY LIGHT CHAMBER | Mar 20, 1981 | Substantially Equivalent | Paul B. Elder Co. |
| K791977 | PSORALITE MARK I | Dec 28, 1979 | Substantially Equivalent | Paul B. Elder Co. |
| K791116 | PSORALITE SERIES 30,000 | Sep 04, 1979 | Substantially Equivalent | Paul B. Elder Co. |
| K761094 | UVA PHOTOTHERAPY SYSTEM | Dec 02, 1976 | Substantially Equivalent | Dermatron Corp. |