# K261370: LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Newdermo Biotech Co., Ltd.
- Decided: Sep 16, 2026 after 142 days
- Product code: NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes)
- Device class: 2
- Regulation: 21 CFR 882.5890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 19 generations back to K943450 (1995). 216 ancestors in all.
No later device cites it as a predicate yet.
0 of 217 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243587: PureLift GLOW, Xtreem Pulse, LLC (2025) Summary page 5.
- K230042: Q-Rejuvalight Pro Facewear (Model: P19-0023), Light Tree Ventures Europe B.V. (2023) Summary page 6.
- K214103: Shani Darden LED light therapy mask, Harpar Grace International (2022) Summary page 6.
- K240360: Wrinkle Treatment Device (JM2), Shenzhen Qianyu Technology Co., Ltd. (2024) Summary page 6.
- K220198: Medi Lift PLUS, Ya-Man, Ltd. (2023) Summary page 7.
- K252146: Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209), Shenzhen Siken 3D Technology Development Co., Ltd. (2025) Summary page 7.

## Cited in the summary but kept off the family tree
- K230293: TheraFace Mask, Therabody, Inc. (2023). Our reading of the summary gave K230293, FDA’s number for TheraFace Mask (Therabody, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Wrinkle Treatment Device (JM2)”. Kept off the family tree. Summary page 7.

## Indications for use
1.Red light + Near-Infrared light: Intended for treat full face wrinkles; 2.Red light + Amber light + Dark Red light + Deep Near-Infrared light: Intended for treat full face wrinkles; 3.Dark Red light + Deep Near-Infrared light: Intended for treat full face wrinkles; 4 Blue light: Intended for treatment of mild to moderate inflammatory acne; 5.The Pulse mode is indicated for facial stimulation.

Source page: https://510kreport.com/device/K261370
Methodology: https://510kreport.com/methodology