# K260129: Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Apr 15, 2026 after 89 days
- Product code: OLI (Fat Reducing Low Level Laser)
- Device class: 2
- Regulation: 21 CFR 878.5400
- 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). 185 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 187 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K232977: Biophotas Celluma CONTOUR, Biophotas, Inc. (2023) Summary page 6.
- K223893: Infrared Heat (Model: E0221), Light Tree Ventures Europe B.V. (2023) Summary page 6.
- K150098: LightStim Professional 2-Panel Light, Led Intellectual Properties, LLC (2015) Summary page 6.

## Most influential descendants
- K260715: CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) (2026), 0 descendants of its own

## Indications for use
For Model ZLD-05: - Mode 1: The Lumaflex Panel is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. - Mode 2: The Lumaflex Panel is intended for use in the treatment of full-face wrinkles. - Mode 3: The Lumaflex Panel is intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. For Model ZLD-05A: - Mode 1: The Lumaflex Panel is intended for use in the treatment of full-face wrinkles. - Mode 2: The Lumaflex Panel is intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. For Model ZLD-05APro: - Mode 1: The Lumaflex Panel is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs. - Mode 2: The Lumaflex Panel is intended to deliver heat in the near infra-red spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis, and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. - Model 3: The Lumaflex Panel is intended to deliver heat in the red and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.

Source page: https://510kreport.com/device/K260129
Methodology: https://510kreport.com/methodology