# K243993: Photon Therapy Apparatus (BL-10)

- Pathway: 510(k) (Traditional)
- Applicant: Xemis Medical Technology (Shenzhen) Co., Ltd.
- Decided: Mar 13, 2025 after 77 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: 18 generations back to K943450 (1995). 241 ancestors in all.
No later device cites it as a predicate yet.
0 of 242 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222751: LED Light Therapy Device, KN-7000L, Xuzhou Kernel Medical Equipment Co., Ltd. (2023) Summary page 5.
- K190938: Phototherapy System, Shanghai Apolo Medical Technology Co., Ltd. (2019) Summary page 5.
- K200104: Oxylight, Raja Trading Company, Inc. (2020) Summary page 5.

## Indications for use
Photon therapy apparatus 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±8nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The blue light (417±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The Yellow light (590±8nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles and rhytides. The infrared light (830±8nm 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/K243993
Methodology: https://510kreport.com/methodology