Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4630](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4630) → KGL — Cabinet, Phototherapy (Puva)

# KGL · Cabinet, Phototherapy (Puva)

_General, Plastic Surgery · 21 CFR 878.4630 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGL

## Overview

- **Product Code:** KGL
- **Device Name:** Cabinet, Phototherapy (Puva)
- **Regulation:** [21 CFR 878.4630](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4630)
- **Device Class:** 2
- **Review Panel:** [General, Plastic Surgery](/submissions/SU)
- **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](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGL/K852575.md) | WALDMANN F85/100W PUVA | Sylvania Lighting Products | Aug 16, 1985 | SESD |
| [K841795](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGL/K841795.md) | UV 8001K, PUVA 800, PUVA 180/200 1000 | Waldmann Lighting Co. | Aug 30, 1984 | SESE |
| [K820280](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGL/K820280.md) | SPECTRA 305/350 | Ultralite | Mar 5, 1982 | SESE |
| [K810668](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGL/K810668.md) | HO-B-LITE VI UNIT | National Biological Corp. | Apr 23, 1981 | SESE |
| [K810358](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGL/K810358.md) | PHOTOTHERAPY LIGHT CHAMBER | Paul B. Elder Co. | Mar 20, 1981 | SESE |
| [K791977](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGL/K791977.md) | PSORALITE MARK I | Paul B. Elder Co. | Dec 28, 1979 | SESE |
| [K791116](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGL/K791116.md) | PSORALITE SERIES 30,000 | Paul B. Elder Co. | Sep 4, 1979 | SESE |
| [K761094](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGL/K761094.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGL](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KGL)

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