# K190938: Phototherapy System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Apolo Medical Technology Co., Ltd.
- Decided: Jun 26, 2019 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: 10 generations back to K943450 (1995). 92 ancestors in all.
16 later devices descend from it; 5 cite it directly.
0 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120460: Smartlux, Medmix Co., Ltd. (2012) Summary page 4.

## Most influential descendants
- K222751: LED Light Therapy Device, KN-7000L (2023), 11 descendants of its own
- 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
- K200659: Dermalux Tri-Wave MD (2020), 3 descendants of its own
- K250761: KALA Therapy Wand (Model: KALA-03) (2025), 1 descendant of its own

## Indications for use
Phototherapy Systems 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/K190938
Methodology: https://510kreport.com/methodology