# K240089: Face Patches (MT-12MA, MT-12MC)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Apr 10, 2024 after 89 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). 266 ancestors in all.
16 later devices descend from it; 6 cite it directly.
0 of 283 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230720: LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001, Light Tree Ventures Europe B.V. (2023) Summary page 5.
- K221946: LED Light Therapy Mask (model: MK66R-B), Light Tree Ventures Europe B.V. (2022) Summary page 5.
- K200104: Oxylight, Raja Trading Company, Inc. (2020) Summary page 6.

## Most influential descendants
- K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) (2024), 6 descendants of its own
- K242593: CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) (2025), 3 descendants of its own
- K243492: Ulike Reglow Light Therapy Device (UM10) (2025), 3 descendants of its own
- K251588: LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) (2025), 2 descendants of its own
- K250761: KALA Therapy Wand (Model: KALA-03) (2025), 1 descendant of its own

## Indications for use
Face Patches (Model: MT-12MA) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne. Face Patches (Model: MT-12MC) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne and full-face wrinkles (including periorbital wrinkles).

Source page: https://510kreport.com/device/K240089
Methodology: https://510kreport.com/methodology