# K223919: B.Light Clear Evo and B.Light Restore Evo

- Pathway: 510(k) (Traditional)
- Applicant: Bemer Int AG
- Decided: Sep 23, 2023 after 268 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: 17 generations back to K943450 (1995). 171 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 174 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202390: Aduro Light Beauty Mask, Shenzhen Kaiyan Medical CO, Ltd. (2021) Summary page 4.
- K210948: Omnilux CLEAR, Globalmed Technologies (2021) Summary page 4.
- K180847: Neutrogena Light Therapy Acne Mask+, Johnson & Johnson Consumer, Inc. (2018) Summary page 4.
- K222377: Led Mask Platinum Md, Cellreturn Co., Ltd. (2022) Summary page 4.

## Most influential descendants
- K252642: Microcurrent Facial Device (CEC101, EEI101) (2025), 0 descendants of its own
- K251825: Jmoon FlexGlow Light Therapy Device (JD20U SP, JD20U SG) (2025), 0 descendants of its own

## Indications for use
B.Light Clear Evo: — The device is intended for over-the-counter (OTC) use to treat patients with mild to moderate acne vulgaris on the face. B.Light Restore Evo: — Use of light-based treatment to reduce wrinkles on the face.

Source page: https://510kreport.com/device/K223919
Methodology: https://510kreport.com/methodology