# K141555: Advantage

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Nov 6, 2014 after 147 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 K910422 (1992). 106 ancestors in all.
14 later devices descend from it; 1 cites it directly.
0 of 121 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113502: Advantage Laser System, Lutronic Corporation (2012) Summary page 6.
- K133319: ET Lightsheer 1060, High Speed Lightsheer 1060, Lumenis, Ltd. (2014) Summary page 6.

## Most influential descendants
- K180719: InMode Diolaze System (2018), 13 descendants of its own
- K191321: Primelase Excellence (2019), 8 descendants of its own
- K193367: elysion-pro (2020), 3 descendants of its own
- K221571: InMode Multi-system (2022), 2 descendants of its own
- K201594: Primelase Excellence (2020), 2 descendants of its own

## Indications for use
The ADVANTAGE Laser System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The ADVANTAGE Laser System is intended for use on all skin types (Fitzpatrick skin types I — VI), including tanned skin. The ADVANTAGE Laser System with D1-800 Handpiece is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. The ADVANTAGE Laser System with D1-800 Handpiece is also indicated for hair removal, permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9, and 12 months, and the treatment of benign pigmented lesions and leg veins. The ADVANTAGE Laser System with D3-800 Handpiece is indicated for hair removal and permanent hair reduction defined as the long-term stable reduction in the number of hairs re-growing after the last treatment measured at 6, 9, and 12 months. The ADVANTAGE Laser System with D1-1064 Handpiece is intended for treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions. The ADVANTAGE Laser System with D1-1064 Handpiece is intended for hair removal, permanent hair reduction, and the treatment of Pseudofolliculitis Barbae (PFB). Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. The ADVANTAGE Laser System with D1-1064 Handpiece is intended for the treatment of benign pigmented lesions, including age spots, solar lentigines, café-au-lait spots, nevi of Ota/Ito, melasma, Becker’s nevi and other benign pigmented lesions. The ADVANTAGE Laser System with D1-1064 Handpiece is also intended for treatment of wrinkles. The ADVANTAGE Laser System with D1-1064 Handpiece is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Source page: https://510kreport.com/device/K141555
Methodology: https://510kreport.com/methodology