FDA.reportPublic FDA data

Soprano Titanium System 230V

Primary DI
17290110121829
Brand
Soprano Titanium System 230V
Company
ALMA LASERS LTD.
Model
1
Catalog number
AASP05091845BSR0001
Device description
The Alma Lasers Soprano Titanium Laser System consists of:•System console (contains the laser diodes, the system software, power supply, andvarious 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 simultaneouslyPremarket Notification Traditional 510(k) Section 8: Page 2 of 4Alma Lasers Soprano Titanium• 810 nm applicator• 755 nm applicator• Small NIR applicator• Footswitch and other laser safety accessories
Published
2022-11-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEXPowered Laser Surgical Instrument
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222064000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222064000The Alma Soprano TitaniumAlma Lasers, Inc.2022-10-12GEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290110121829PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729011012182917290110121829

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological diode laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to remove unwanted body hair (e.g., armpit, leg/arm, back, chest, bikini line, and face). It is intended to be used by a trained professional to emit pulsed light of a wavelength around 808 nm, delivered by a dedicated handpiece, to destroy hair follicles by heat. Also known as a laser epilator, it typically includes a control unit with dedicated software and user interface, delivery handpiece, and foot-switch.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532283264
Device count
1
Serial number
true
Manufacturing date on label
true

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