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Sun Tanning Bed Model EC-3RF

by Mottek Intl. Corp.

510(k) K853692

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)SESE Substantially Equivalent · Traditional NumberK853692 Date1 Oct 1985ClearedStatusActive

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  • Withdrawn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
Device Class
Class II
Regulation
21 CFR Part 878.4630
Advisory Committee
General, Plastic Surgery
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

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

The Sun Tanning Bed Model EC-3RF is a dermatological device that emits ultraviolet light for tanning purposes. It is classified as a light, ultraviolet, dermatological device intended for use in general and plastic surgery settings.

This device is supplied by Mottek Intl. Corp. and has FDA 510(k) clearance with decision code SESE. The device is class 2 and regulated under product code FTC. It is not specified as single-use or reusable, and no information regarding MRI safety, sterility, or storage conditions is provided.

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Questions

AI-generated answers, 26 Sep 2026

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

  • What is the Sun Tanning Bed Model EC-3RF used for?

    The Sun Tanning Bed Model EC-3RF is a dermatological device that emits ultraviolet light for tanning purposes. It is intended for use in general and plastic surgery settings.

  • How is the Sun Tanning Bed Model EC-3RF supplied?

    The device is supplied by Mottek Intl. Corp. No information is provided regarding whether it is single-use or reusable, or if it requires special storage conditions.

  • What is the regulatory status of the Sun Tanning Bed Model EC-3RF?

    The device has FDA 510(k) clearance with decision code SESE, indicating it is substantially equivalent to predicate devices. It is classified as class 2 and regulated under product code FTC.

  • Is the Sun Tanning Bed Model EC-3RF sterile?

    No information regarding sterility is provided for the Sun Tanning Bed Model EC-3RF in the available device data.