# K223642: LED Lip Perfector, model: ZC-05

- Pathway: 510(k) (Traditional)
- Applicant: Light Tree Ventures Europe B.V.
- Decided: Mar 9, 2023 after 93 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K101190 (2010). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172662: reVive Perioral, Led Technologies, Inc. (2018) Summary page 4.

## Indications for use
The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fine lines and wrinkles and increase in circulation within the perioral region.

Source page: https://510kreport.com/device/K223642
Methodology: https://510kreport.com/methodology