# K220064: Synergy Marble (Model: Opasm)

- Pathway: 510(k) (Traditional)
- Applicant: Yrs Group, Inc.
- Decided: Jul 22, 2022 after 193 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K943450 (1995). 160 ancestors in all.
No later device cites it as a predicate yet.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202055: Looper (Model: ZX-579S), Heat IN A Click, LLC (2021) Summary page 4.

## Indications for use
SYNERGY MARBLE is a hand-held device for over-the counter aesthetic purposes. The device red light and amber light are intended for the use in treating wrinkles on the face, and the blue light is intended for the treatment of the mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K220064
Methodology: https://510kreport.com/methodology