# K200751: Photodynamic Therapy (PDT) Equipment

- Pathway: 510(k) (Traditional)
- Applicant: Shangdong Huamei Technology Co., Ltd.
- Decided: May 21, 2020 after 59 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: 11 generations back to K943450 (1995). 93 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 95 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 5.

## Most influential descendants
- K230342: Phototherapy System  (OL-PDT950) (2023), 0 descendants of its own

## Indications for use
The Photodynamic Therapy (PDT) Equipment use of the red, blue and infrared regions of the spectrum is intended to emit energy to treat dermatological conditions. The blue light (415nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. The red light (630nm 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/K200751
Methodology: https://510kreport.com/methodology