# K191693: BC-5

- Pathway: 510(k) (Abbreviated)
- Applicant: Reveallux, Corp
- Decided: Nov 1, 2019 after 129 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.
No later device cites it as a predicate yet.
0 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082586: Lightwave Professional Deluxe, Lightwave Technologies, LLC (2010) Summary page 4.

## Indications for use
BC-5 Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions. BC-5 Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. BC-5 Red and Blue light in combination is intended to emit energy in the red and blue region of the spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris. BC-5 Red and Infrared light in combination is intended to emit energy in the red and infrared region of the spectrum to treat dermatological conditions, specifically indicated to treat periorbital wrinkles. BC-5 Infrared is intended to emit energy in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; 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/K191693
Methodology: https://510kreport.com/methodology