# K140009: Soprano Ice Multi-Application & Multi-Technology Platform

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Ltd.
- Decided: Aug 29, 2014 after 239 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: 19 generations back to K943450 (1995). 514 ancestors in all.
57 later devices descend from it; 7 cite it directly.
0 of 572 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112031: Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family of Soprano XL Multi-Application, Alma Lasers, Inc. (2011) Summary page 5.
- K102716: Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms, Alma Lasers, Inc. (2010) Summary page 5.
- K083848: Alma Lasers Soprano XL Multi-Application Platform, Alma Lasers, Ltd. (2009) Summary page 5.
- K080318: Alma Laser Nir Module, Alma Lasers, Ltd. (2008) Summary page 5.
- K090571: Alma Lasers ALEX755 Module, Alma Lasers, Ltd. (2009) Summary page 5.
- K101916: Joule Multi-Platform System, Sciton, Inc (2011) Summary page 5.
- K083207: Ultrawave Iii EX 1320, Quanta System Spa (2008) Summary page 5.

## Most influential descendants
- K143519: The MeDioStar NeXT Family (2015), 32 descendants of its own
- 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
- K180719: InMode Diolaze System (2018), 13 descendants of its own
- K152714: Quanta Forte (2015), 13 descendants of its own

## Indications for use
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano XLi and Soprano ICE] includes Diode Laser and NIR Modules Diode Laser Modules: The indications for use for the 810nm Modified Diode Laser Module 1.2 cm² include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode is 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. The treatment of benign vascular and pigmented lesions. (The Laser Blanch (LB) Mode) Use on all skin types (Fitzpatrick I-VI), including tanned skin. (HR, SHR and LB Modes) Optional Tapered Light Guide: It is intended for the same use as the device. The indications for use for the 810nm Modified Diode Laser Module 2 cm² include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode is 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. Use on all skin types (Fitzpatrick I-VI), including tanned skin. (HR and SHR Modes) The indications for use for the 755nm Diode Laser Module include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode is 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. The treatment of benign vascular and pigmented lesions. (The Laser Blanch Mode) Use on all skin types (Fitzpatrick I-VI), including tanned skin. (HR, SHR and Laser Blanch Modes) NIR Modules The indications for use for NIR Modules are: 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.

Source page: https://510kreport.com/device/K140009
Methodology: https://510kreport.com/methodology