# K102716: Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms

- Pathway: 510(k) (Special)
- Applicant: Alma Lasers, Inc.
- Decided: Sep 28, 2010 after 7 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: 9 generations back to K910422 (1992). 57 ancestors in all.
124 later devices descend from it; 4 cite it directly.
0 of 182 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052874: Soprano Hair Removal Diode Laser, Msq (M2), Ltd. (2005) Summary page 1.
- K083848: Alma Lasers Soprano XL Multi-Application Platform, Alma Lasers, Ltd. (2009) Summary page 1.
- K080318: Alma Laser Nir Module, Alma Lasers, Ltd. (2008) Summary page 1.

## Most influential descendants
- K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application (2011), 118 descendants of its own
- 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

## Indications for use
The Modified Alma Lasers Family of SOPRANO XLTM Multi-Application Platforms [Soprano XL, Soprano XLi] is intended for use in dermatologic and general surgical procedures. The Alma Lasers Family of SOPRANO XLTM Multi-Application Platforms [Soprano XL, Soprano XLi] includes a Diode Laser Module and an optional NIR Module. The Diode Laser Module: The HIR Mode is intended for hair removal, permanent hair reduction. The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions. The NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain. The Modified Alma Lasers Family of Soprano™ Diode Laser Systems [Soprano XL, Soprano XLi] is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Source page: https://510kreport.com/device/K102716
Methodology: https://510kreport.com/methodology