# K011935: Rejuvenique Model #RJV10

- Pathway: 510(k) (Traditional)
- Applicant: Salton, Inc.
- Decided: Aug 8, 2001 after 48 days
- Product code: NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
119 later devices descend from it; 6 cite it directly.
0 of 120 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) TENS devices: named in the summary without a submission number

## Most influential descendants
- K072260: Nuface, Model NU-4003 (2007), 114 descendants of its own
- K103472: Nuface Plus (2011), 94 descendants of its own
- K171821: 2 Face / Face Evolution (2018), 58 descendants of its own
- K212155: TheraFace LED (2021), 42 descendants of its own
- K223544: LED light therapy mask (FM-01, FM-02, FM-03) (2023), 39 descendants of its own

## Indications for use
The Rejuvenique System is indicated for cosmetic use.

Source page: https://510kreport.com/device/K011935
Methodology: https://510kreport.com/methodology