Manufacturer
Alma Lasers, Inc.The Alma Soprano Titanium
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K222064
- Device name
- The Alma Soprano Titanium
- Company
- Alma Lasers, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2022-07-13
- Decision date
- 2022-10-12
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalVascular treatment
- Primary application
- Hair removal
- Classification source
- AI classified
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 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 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.
Intended 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. 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. 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. 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.
Device Description
The Alma Lasers Soprano Titanium Laser System consists of: System console (contains the laser diodes, the system software, power supply, and various other electronic and mechanical parts), Operator control panel with touch-screen technology (GUI), Trio applicator with 1064 nm, 810 nm and 755 nm wavelengths applied simultaneously, 810 nm applicator, 755 nm applicator, Small NIR applicator, Footswitch and other laser safety accessories.
Summary parsed at:2026-06-01 05:40:15 UTC
Predicate devices
1Modified 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
K222064 references 1 predicate/reference device
Cited as predicate
7SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC
Alma Harmony
The Alma Soprano Titanium
Diode Laser System
VEGA
Diode laser system (Night Universe; Predator)
Diode Laser Therapy Systems (WLA-02)
7 submissions cite K222064 as a predicate
