# K230371: The Alma Soprano Titanium

- Pathway: 510(k) (Special)
- Applicant: Alma Lasers, Inc.
- Decided: Feb 22, 2023 after 9 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: 25 generations back to K943450 (1995). 566 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 569 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222064: The Alma Soprano Titanium, Alma Lasers, Inc. (2022) Summary page 5.

## Most influential descendants
- K241951: Lasya-Trinity (2024), 0 descendants of its own
- K231896: Diode Laser Therapy System (2024), 0 descendants of its own

## Indications for use
The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include: The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser HR module include: Benign vascular and vascular dependent lesions. 810nm Applicator Soprano Titanium 810 nm applicator intended use and indications for use: 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) 755nm applicator Soprano Titanium 755 nm applicator intended use and indications for use: 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. • Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes) NIR Applicator NIR Applicator intended use and indications for use 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/K230371
Methodology: https://510kreport.com/methodology