# K230124: LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)

- Pathway: 510(k) (Traditional)
- Applicant: Light Tree Ventures Europe B.V.
- Decided: Mar 15, 2023 after 57 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). 114 ancestors in all.
10 later devices descend from it; 1 cites it directly.
0 of 125 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K214103: Shani Darden LED light therapy mask, Harpar Grace International (2022) Summary page 5.

## Most influential descendants
- K230042: Q-Rejuvalight Pro Facewear (Model: P19-0023) (2023), 9 descendants of its own
- K251588: LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) (2025), 2 descendants of its own
- K261370: LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) (2026), 0 descendants of its own
- K261496: LED Light Therapy Masks (PE748, PE749, PE756) (2026), 0 descendants of its own
- K260715: CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) (2026), 0 descendants of its own

## Indications for use
The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K230124
Methodology: https://510kreport.com/methodology