Skip to content

Rejuvenique Model #RJV10

by Salton, Inc.

510(k) K011935

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 NumberK011935 Date8 Aug 2001ClearedStatusActive

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  • Withdrawn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
NFO
Device Class
Class II
Regulation
21 CFR Part 882.5890
Advisory Committee
Neurology
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 Rejuvenique Model #RJV10 is a transcutaneous electrical stimulator for aesthetic purposes. It is a Class II medical device designed for cosmetic use according to its FDA classification.

The device is manufactured by Salton, Inc. and was cleared by the FDA on August 8, 2001 under 510(k) number K011935. It is regulated under product code NFO and regulation number 882.5890. The device is reviewed by the Neurology advisory committee and is intended for aesthetic purposes.

Other devices from Salton, Inc.

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 Rejuvenique Model #RJV10 used for?

    The Rejuvenique Model #RJV10 is a transcutaneous electrical stimulator designed specifically for aesthetic purposes. It is a Class II medical device that delivers electrical stimulation through the skin for cosmetic applications.

  • Is the Rejuvenique Model #RJV10 a single-use or reusable device?

    The device data does not specify whether the Rejuvenique Model #RJV10 is single-use or reusable. This information would be found in the device's instructions for use, which are not provided in the available data.

  • What is the regulatory status of the Rejuvenique Model #RJV10?

    The Rejuvenique Model #RJV10 is a Class II medical device that received FDA clearance on August 8, 2001 under 510(k) number K011935. It is regulated under product code NFO and regulation number 882.5890, and was reviewed by the Neurology advisory committee.

  • How is the Rejuvenique Model #RJV10 supplied?

    The device data does not specify how the Rejuvenique Model #RJV10 is supplied, including packaging, quantity per package, or included accessories. This information would typically be found in the device's instructions for use or product catalog.