# K200983: Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine

- Pathway: 510(k) (Traditional)
- Applicant: Ningbo Hesi Electric Co., Ltd.
- Decided: Jul 14, 2021 after 456 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: 14 generations back to K943450 (1995). 144 ancestors in all.
46 later devices descend from it; 5 cite it directly.
0 of 191 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152280: BioPhotas Celluma3, Biophotas, Inc. (2016) Summary page 5.
- K171323: Biophotas CELLUMA3, Biophotas, Inc. (2017) Summary page 5.

## Most influential descendants
- K223544: LED light therapy mask (FM-01, FM-02, FM-03) (2023), 39 descendants of its own
- K241857: LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) (2024), 21 descendants of its own
- 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
- K212275: Dermalux Flex MD (2021), 4 descendants of its own
- K242385: LED Therapy Mask (MN1, M226) (2025), 3 descendants of its own

## Indications for use
The LED FACIAL LIGHT THERAPY MASK (Model: HK207) is intended to: - The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris. - The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles. The FLEXIBLE LED LIGHT THERAPY (Model: HK209) is intended to: - The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris. - The device emitting energy in the red and infrared spectrum is intended for the treatment of full-face wrinkles - The device is intended to deliver heat in the IR 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/K200983
Methodology: https://510kreport.com/methodology