# K250189: AdvaTx

- Pathway: 510(k) (Traditional)
- Applicant: Advalight Aps
- Decided: Apr 1, 2025 after 69 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: 20 generations back to K943450 (1995). 509 ancestors in all.
No later device cites it as a predicate yet.
0 of 510 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132976: Advatx, Advalight Aps (2014) Summary page 6.

## Indications for use
The ADVATx at 589 nm is indicated for use for dermatologic treatment of benign cutaneous vascular lesions including but not limited to: treatment of wrinkles, periocular wrinkles, periorbital wrinkles, facial and leg telangiectasia, rosacea. cherry ańgiomas, port wine stains, hemangiomas and venous lakes, angioma, spider angioma, Poikiloderma of Civatte, inflammatory acne vulgaris, verrucae/ warts, scars, striae, psoriasis and the treatment of benign pigmented lesions. The ADV ATx at 1319 nm 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/K250189
Methodology: https://510kreport.com/methodology