# K181298: Harmony XL Multi-Application Platform

- Pathway: 510(k) (Special)
- Applicant: Alma Lasers, Inc.
- Decided: Jun 13, 2018 after 28 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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: 21 generations back to K943450 (1995). 516 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 520 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 4.
- K141237: Harmony Lite, Alma, Inc. (2015) Summary page 4.

## Most influential descendants
- K230308: Alma Harmony (2023), 2 descendants of its own
- K233024: Alma Harmony (2024), 1 descendant of its own
- K252561: BTL-754FF (2026), 0 descendants of its own

## Indications for use
The Dye VL Handpiece (500-600 nm) is indicated for: • The treatment of benign pigmented lesions including café -au-lait (macules), lentigines (senile and solar), freckles (ephelides), chloasma, nevi, nevus spillus, nevus of Ota, and Becker’s Nevi. • The treatment of other pigmented cutaneous lesions including verrucae, skin tags, keratosis, and plaques. • The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations. • Use on skin types (Fitzpatrick I-V).

Source page: https://510kreport.com/device/K181298
Methodology: https://510kreport.com/methodology