# K083848: Alma Lasers Soprano XL Multi-Application Platform

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Ltd.
- Decided: Apr 14, 2009 after 111 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: 3 generations back to K001746 (2000). 7 ancestors in all.
125 later devices descend from it; 3 cite it directly.
0 of 133 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001746: Lightsheer Pulsed Diode Array Laser System (Family of Products), Coherent Star (2000)
- K003614: Lightsheer Pulsed Diode Array Laser System, Coherent Star (2001) Summary page 1.
- K013028: Palomar SLP 1000, Palomar Medical Products, Inc. (2001) Summary page 1.
- K050900: Mediostar XT, Asclepion Laser Technologies GmbH (2005) Summary page 1.
- K052874: Soprano Hair Removal Diode Laser, Msq (M2), Ltd. (2005) Summary page 1.
- K053628: Lightsheer Duet Laser System, Lumenis, Inc. (2006) Summary page 1.

## Most influential descendants
- K102716: Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms (2010), 124 descendants of its own
- 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

## Indications for use
The SOPRANO XLTM Multi-Application Platform includes a Diode Laser Module and an optional NIR Module. The Diode Laser Module: The HR 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 SOPRANO XLTM Multi-Application Platform is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.

Source page: https://510kreport.com/device/K083848
Methodology: https://510kreport.com/methodology