# K113502: Advantage Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Lutronic Corporation
- Decided: Apr 5, 2012 after 132 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: 1 generation back to K053628 (2006). 1 ancestor in all.
15 later devices descend from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053628: Lightsheer Duet Laser System, Lumenis, Inc. (2006) Summary page 1.

## Most influential descendants
- K141555: Advantage (2014), 14 descendants of its own
- 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

## 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 H1 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 H1 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 H3 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.

Source page: https://510kreport.com/device/K113502
Methodology: https://510kreport.com/methodology