# K170626: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Inc.
- Decided: May 31, 2017 after 90 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: 22 generations back to K943450 (1995). 545 ancestors in all.
24 later devices descend from it; 2 cite it directly.
0 of 570 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153671: Family of CoolGlide Aesthetic Lasers, Cutera, Inc. (2016) Summary page 4.
- K132185: Family of Coolglide Aesthetic Lasers, Cutera, Inc. (2013) Summary page 4.

## Most influential descendants
- K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules (2018), 22 descendants of its own
- K222064: The Alma Soprano Titanium (2022), 14 descendants of its own
- K251329: Diode laser device (RF3120-BI) (2025), 2 descendants of its own
- K230308: Alma Harmony (2023), 2 descendants of its own
- K230371: The Alma Soprano Titanium (2023), 2 descendants of its own

## Indications for use
The indications for use for the Soprano1064nm Diode Laser Module include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. Treatment of Pseudo folliculitis Barbae (PFB) Use on all skin types (Fitzpatrick I-VI), including tanned skin.

Source page: https://510kreport.com/device/K170626
Methodology: https://510kreport.com/methodology