# 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

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Inc.
- Decided: Jan 9, 2018 after 172 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: 23 generations back to K943450 (1995). 564 ancestors in all.
22 later devices descend from it; 7 cite it directly.
0 of 587 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform, Alma Lasers, Ltd. (2014) Summary page 5.
- K170626: Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform, Soprano YAG Hand piece, Alma Lasers, Inc. (2017) Summary page 5.

## Most influential descendants
- 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
- K201594: Primelase Excellence (2020), 2 descendants of its own

## Indications for use
The device is intended for use in dermatologic and general surgical procedures. TKH 6RSUDQR WULR 'LRGH /DVHU 0RGXOH is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano 5SJP Diode Laser Module include: Benign vascular and vascular dependent lesions removal. 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. 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 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. 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 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. 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 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. 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) The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating. 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/K172193
Methodology: https://510kreport.com/methodology