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

The device is intended for use in dermatologic and general surgical procedures. The indications for use for the Soprano 810nm 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).
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 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,
- The relaxation of muscles; may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

The device is intended for use in dermatologic and general surgical procedures.

The subject device, Alma Lasers Soprano Trio Diode Laser Module, is an additional hand piece intended to be used with previously cleared Soprano platforms. The system is intended to be used in user facilities such as hospitals, physicians' offices, and medical spas. Its major components are the main console unit, foot switch, and individual modules. The module's operation involves emission of laser (diode) energy through the hand piece to the patient's skin. The device is re-usable and non-sterile; instructions for cleaning its components between uses are provided in the labeling.