# K082586: Lightwave Professional Deluxe

- Pathway: 510(k) (Traditional)
- Applicant: Lightwave Technologies, LLC
- Decided: Jan 4, 2010 after 483 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.
4 later devices descend from it; 4 cite it directly.
0 of 97 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030883: Omnilux Blue, Photo Therapeutics Limited (2003) Summary page 1.
- K030426: Omnilux Red, Photo Therapeutics Limited (2003) Summary page 1.
- K043317: Omnilux Plus, Photo Therapeutics Limited (2005) Summary page 1.
- K050216: Omnilux Revive and Omnilux Plus, Photo Therapeutics Limited (2005) Summary page 1.

## Most influential descendants
- K191693: BC-5 (2019), 0 descendants of its own
- K142256: Applied BioPhotonics Phototherapy System ABPT1003 (2015), 0 descendants of its own
- K131142: Genesis Led Wands (2013), 0 descendants of its own
- K100628: Plasmaluxls (2010), 0 descendants of its own

## Indications for use
The LIGHTWAVE Deluxe Red light is indicated for use in dermatology for treatment of superficial, benign vascular, and pigmented lesions. The LIGHTWAVE Deluxe Red and Blue light 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. THE LIGHTWAVE Deluxe Blue light is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris. THE LIGHTWAVE Deluxe Red and Blue light combination is intended to emit energy in the red and infra-red region of the spectrum for use in dermatology for the treatment of periorbital wrinkles. THE LIGHTWAVE Deluxe Infrared Light 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/K082586
Methodology: https://510kreport.com/methodology