# K132976: Advatx

- Pathway: 510(k) (Traditional)
- Applicant: Advalight Aps
- Decided: Apr 17, 2014 after 206 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: 19 generations back to K943450 (1995). 508 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 510 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032397: Dual Yellow Laser, Model Dual Yellow D10B, Norseld Pty., Ltd. (2004) Summary page 1.
- K043251: Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B, Candela Corp. (2005) Summary page 1.
- K101916: Joule Multi-Platform System, Sciton, Inc (2011) Summary page 1.
- K033176: Tristar Aesthetic Workstation Laser, Cynosure, Inc. (2004) Summary page 3.

## Most influential descendants
- K250189: AdvaTx (2025), 0 descendants of its own

## Indications for use
The ADVATx at 589 nm is indicated for use for dermnatologic treatment of benign cutaneous vascular lesions including but not limited to: treatment of wrinkles, periocular wrinkles, periorbital wrinkles, facial and leg telangiectasia, rosacea, cherry aigiomnas, port wine stains, hemangiomas and venous lakes, angioma, spider angioma, Poikiloderma of Civatte, inflammatory acne vulgaris, verrucael watts, scars, stuica, and psoriasis. The ADVATx at 1319 em is indicated for treatment of fine lines and wrinkles. Treatment of atrophic acne scars. Treatment of mild and moderate inflammatory acne vulgaris.

Source page: https://510kreport.com/device/K132976
Methodology: https://510kreport.com/methodology