# K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application

- Pathway: 510(k) (Special)
- Applicant: Alma Lasers, Inc.
- Decided: Sep 13, 2011 after 60 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: 10 generations back to K910422 (1992). 58 ancestors in all.
118 later devices descend from it; 7 cite it directly.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102716: Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms, Alma Lasers, Inc. (2010) Summary page 1.
- K083848: Alma Lasers Soprano XL Multi-Application Platform, Alma Lasers, Ltd. (2009) Summary page 1.

## Most influential descendants
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own
- K123483: Diode Laser (2013), 53 descendants of its own
- K141973: Diode Laser Hair Removal System (2014), 48 descendants of its own
- K162659: Diode Laser Hair Removal System (2017), 40 descendants of its own
- K143519: The MeDioStar NeXT Family (2015), 32 descendants of its own

## Indications for use
The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use in dermatologic and general surgical procedures. The Alma Lasers Modified Diode Laser Module (used with the Alma Lasers Family of Soprano XL Multi-Application Platforms): * The HR Mode is intended for hair removal, permanent hair reduction. * The SHR Mode is intended for hair removal, permanent hair reduction. * The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions. The Alma Lasers Family of Soprano XL Multi-Application Platforms is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Source page: https://510kreport.com/device/K112031
Methodology: https://510kreport.com/methodology