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Phoenix U.V.A. Suntan Beds

by Phoenix U.V.A., Ltd.

510(k) K854594

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SN Traditional NumberK854594 Date30 Jan 1986DecidedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FTC
FDA applicant
Phoenix U.V.A. , Ltd.
Device Class
Class II
Regulation
21 CFR Part 878.4630
Advisory Committee
General, Plastic Surgery
FDA Decision
SN

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a light, ultraviolet, dermatological device used for general and plastic surgery applications. It is substantially equivalent for some indications as determined by FDA 510(k) clearance.

The device is supplied as a suntan bed system, classified as a Class II medical device under regulation number 878.4630. It was cleared through the traditional 510(k) pathway with K number K854594 and is manufactured by Phoenix U.V.A., Ltd. in Meservey, Iowa.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What surgical specialties is the Phoenix U.V.A. Suntan Beds intended for?

    The device is indicated for use in general and plastic surgery settings, where ultraviolet light can assist with dermatological procedures such as skin preparation and therapeutic tanning. Its clearance references these specialties, so clinicians in those fields may incorporate it into their practice.

  • How is the Phoenix U.V.A. Suntan Beds supplied and what class does it belong to?

    It is supplied as a complete suntan‑bed system and is classified as a Class II medical device under regulation number 878.4630. Being a Class II device means it requires special controls and a 510(k) submission to demonstrate substantial equivalence to a legally marketed predicate.

  • Is the Phoenix U.V.A. Suntan Beds a single‑use or reusable system?

    The system is a reusable piece of equipment; it is a permanent installation rather than a disposable item. Users must follow the manufacturer’s cleaning and maintenance procedures to ensure safe, repeated use in clinical environments.

  • What regulatory pathway was used for the Phoenix U.V.A. Suntan Beds and what does that imply?

    The device cleared the traditional 510(k) pathway (K‑number K854594), indicating the FDA found it substantially equivalent to an existing legally marketed device for the same indications. This pathway does not require new clinical trials but does require demonstration of comparable safety and performance.