# K210954: Synergy

- Pathway: 510(k) (Traditional)
- Applicant: Yrs Group, Inc.
- Decided: Jun 29, 2021 after 91 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: 5 generations back to K101190 (2010). 6 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172909: Elevare, Perfectio 4, Omm Imports D/B/A Zero Gravity (2018) Summary page 4.

## Most influential descendants
- K240360: Wrinkle Treatment Device (JM2) (2024), 2 descendants of its own
- K261370: LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) (2026), 0 descendants of its own
- K244020: Wrinkle Treatment Device (JM1, JM2B) (2025), 0 descendants of its own

## Indications for use
The SYNERGY is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face.

Source page: https://510kreport.com/device/K210954
Methodology: https://510kreport.com/methodology