# K180875: Poly Rejuv

- Pathway: 510(k) (Traditional)
- Applicant: Medtek Skincare, LLC
- Decided: Sep 14, 2018 after 164 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: 14 generations back to K943450 (1995). 149 ancestors in all.
No later device cites it as a predicate yet.
0 of 150 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162098: LED Phototherapy Device, Li-Tek Electronic Technology Corporation (2017) Summary page 4.

## Indications for use
The Poly Rejuv Model 633 is intended to emit energy in the red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.

Source page: https://510kreport.com/device/K180875
Methodology: https://510kreport.com/methodology