# K222751: LED Light Therapy Device, KN-7000L

- Pathway: 510(k) (Traditional)
- Applicant: Xuzhou Kernel Medical Equipment Co., Ltd.
- Decided: Feb 1, 2023 after 142 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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). 240 ancestors in all.
11 later devices descend from it; 4 cite it directly.
0 of 252 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190938: Phototherapy System, Shanghai Apolo Medical Technology Co., Ltd. (2019) Summary page 4.
- K200104: Oxylight, Raja Trading Company, Inc. (2020) Summary page 4.

## Most influential descendants
- K241293: LED Light Therapy Device, ELIXIR MD™ (2024), 7 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
- K250761: KALA Therapy Wand (Model: KALA-03) (2025), 1 descendant of its own
- K242151: Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B) (2025), 1 descendant of its own
- K252272: ORA Method LED Gua Sha (GS-04) (2025), 0 descendants of its own

## Indications for use
LED Light Therapy Device use of the red, blue, Yellow and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The red light (633+10nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The blue light (417+£10 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The Yellow light (599+10nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. The infrared light (835+15nm wavelength) is generally use 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 where applied.

Source page: https://510kreport.com/device/K222751
Methodology: https://510kreport.com/methodology