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I.S.M. Product Family Model R3600C

by Intl. Solarium Manufacturer, Inc.

510(k) K854170

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 NumberK854170 Date8 Nov 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  • Withdrawn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, 24 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 I.S.M. Product Family Model R3600C is a light, ultraviolet dermatological device used in general and plastic surgery settings. This device is part of the I.S.M. product family and is designed for dermatological applications.

The device is supplied by Intl. Solarium Manufacturer, Inc. and has FDA 510(k) clearance with the number K854170, classified under product code FTC. It is regulated under 878.4630 and was determined to be substantially equivalent on November 8, 1985.

Other devices from Intl. Solarium Manufacturer, Inc.

Questions

AI-generated answers, 24 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 I.S.M. Product Family Model R3600C used for?

    The I.S.M. R3600C is a light, ultraviolet dermatological device designed for use in general and plastic surgery settings. It is part of the I.S.M. product family and specifically intended for dermatological applications.

  • How is the I.S.M. R3600C supplied and what is its regulatory status?

    The device is supplied by Intl. Solarium Manufacturer, Inc. It has FDA 510(k) clearance with number K854170, classified under product code FTC, and was determined to be substantially equivalent on November 8, 1985.

  • Is the I.S.M. R3600C a single-use device or can it be reused?

    The device data does not specify whether the I.S.M. R3600C is designed for single-use or multiple reuse. For proper handling and safety protocols, please refer to the manufacturer's instructions or contact Intl. Solarium Manufacturer, Inc. directly.

  • What are the storage requirements for the I.S.M. R3600C?

    The device data does not provide specific storage requirements for the I.S.M. R3600C. For proper storage conditions to maintain device integrity, please consult the manufacturer's documentation or contact Intl. Solarium Manufacturer, Inc. for detailed guidance.