# K112351: Ultra Beauty

- Pathway: 510(k) (Traditional)
- Applicant: Johari Digital Healthcare, Ltd.
- Decided: Mar 30, 2012 after 227 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Rejuvenique: named in the summary without a submission number
- (no number) NuFACE: named in the summary without a submission number
- (no number) FaceMaster: named in the summary without a submission number

## Indications for use
Ultra Beauty device is intended for facial stimulation and is indicated for over-the-counter cosmetic use

Source page: https://510kreport.com/device/K112351
Methodology: https://510kreport.com/methodology