# K241203: PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)

- Pathway: 510(k) (Traditional)
- Applicant: Dongguan Hunter Electronic Technology Co., Ltd.
- Decided: Jul 25, 2024 after 86 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 5.

## Indications for use
The PMD Clean Redvolution (All 4005 models) is a hand-held device for over-the counter aesthetic purposes. The red light is intended for the use in treating wrinkles on the face.

Source page: https://510kreport.com/device/K241203
Methodology: https://510kreport.com/methodology