# K233077: FlashHeal 2 (FlashHeal 2.0)

- Pathway: 510(k) (Traditional)
- Applicant: Inwound Aps
- Decided: Jan 18, 2024 after 114 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). 245 ancestors in all.
No later device cites it as a predicate yet.
0 of 246 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.
- K200659: Dermalux Tri-Wave MD, Aesthetic Technology, Ltd. (2020) Summary page 5.
- K221083: Smartlux Mini, Medmix Co., Ltd. (2022) Summary page 5.
- K222751: LED Light Therapy Device, KN-7000L, Xuzhou Kernel Medical Equipment Co., Ltd. (2023) Summary page 5.

## Indications for use
FlashHeal's use of blue, red, and infrared regions of the light spectrum is intended to emit energy to treat and document dermatological conditions. i. The blue light (405 nm wavelength) is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. ii. The red light (625 nm wavelength) is generally indicated to treat superficial, benign vascular, and pigmented lesions. iii. The infrared light (850 nm wavelength) is generally used 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. iv. The red and infrared lights combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. FlashHeal does not diagnose the patient and does not come in contact with the patient at any point.

Source page: https://510kreport.com/device/K233077
Methodology: https://510kreport.com/methodology