# K254025: LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Jun 16, 2026 after 182 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: 19 generations back to K943450 (1995). 291 ancestors in all.
No later device cites it as a predicate yet.
0 of 292 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240089: Face Patches (MT-12MA, MT-12MC), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2024) Summary page 5.
- K243492: Ulike Reglow Light Therapy Device (UM10), Shenzhen Ulike Smart Electronics Co., Ltd. (2025) Summary page 5.
- K242382: décoLITE LED Device, iSMART Developments, Ltd. (2024) Summary page 6.

## Indications for use
M1 is an over-the-counter device that is intended for emit energy in the red and infrared spectrum for use for the treatment of full face and decolletage wrinkles. M2,M3,M5 is an over-the-counter device that is intended for emit energy in the red,infrared, yellow spectrum for use for the treatment of full face wrinkles. M4 is intended for over-the-counter use to treat mild to moderate inflammatory acne on the face.

Source page: https://510kreport.com/device/K254025
Methodology: https://510kreport.com/methodology