← Product Code [FTC](/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC) · K852149

# PORTASUN MODEL 600/LI SUNLAMP (K852149)

_Portasun , Ltd. · FTC · May 31, 1985 · General, Plastic Surgery · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K852149

## Device Facts

- **Applicant:** Portasun , Ltd.
- **Product Code:** [FTC](/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC.md)
- **Decision Date:** May 31, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4630
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory 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.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K852149](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/FTC/K852149)

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