# K230342: Phototherapy System  (OL-PDT950)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Omni Laser Skinology Co., Ltd.
- Decided: Aug 16, 2023 after 189 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). 242 ancestors in all.
No later device cites it as a predicate yet.
0 of 243 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200751: Photodynamic Therapy (PDT) Equipment, Shangdong Huamei Technology Co., Ltd. (2020) Summary page 4.
- K222751: LED Light Therapy Device, KN-7000L, Xuzhou Kernel Medical Equipment Co., Ltd. (2023) Summary page 4.
- K200104: Oxylight, Raja Trading Company, Inc. (2020) Summary page 4.

## Indications for use
he Phototherapy System use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (469nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The red light (633nm wavelength) is generally indicated to treatment of superficial, benign vascular, and pigmented lesions. The infrared light (835nm 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/K230342
Methodology: https://510kreport.com/methodology