Rejuvenique Model #RJV10

FDA 510(k) K011935 · Salton, Inc.

Substantially Equivalent

510(k) numberK011935

Submission

Device name
Rejuvenique Model #RJV10
Applicant
Salton, Inc.
Washington, DC, US
Received
June 21, 2001
Decision date
August 8, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5890
Specialty
Neurology

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Questions and answers

When was Rejuvenique Model #RJV10 cleared by the FDA?

Rejuvenique Model #RJV10 (K011935) received a 510(k) decision of Substantially Equivalent on August 8, 2001, 48 days after the submission was received.

What is the product code of K011935?

The FDA product code is NFO – Stimulator, Transcutaneous Electrical, Aesthetic Purposes, a Class II (moderate risk) device regulated under 21 CFR 882.5890.