# K230013: Silk'n Titan Allways

- Pathway: 510(k) (Traditional)
- Applicant: Silk'N Beauty, Ltd.
- Decided: Aug 30, 2023 after 239 days
- Product code: PAY (Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K943450 (1995). 94 ancestors in all.
No later device cites it as a predicate yet.
0 of 95 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162784: Silk'n HST, Home Skinovations, Ltd. (2017) Summary page 4.

## Indications for use
The Silk’n Titan AllWays is an over-the-counter home use device intended for the non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick skin types I-IV.

Source page: https://510kreport.com/device/K230013
Methodology: https://510kreport.com/methodology