DEVICE: Soprano Titanium System 230V (17290110121829)
Device Identifier (DI) Information
Soprano Titanium System 230V
1
In Commercial Distribution
AASP05091845BSR0001
ALMA LASERS LTD.
1
In Commercial Distribution
AASP05091845BSR0001
ALMA LASERS LTD.
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 simultaneously
Premarket Notification Traditional 510(k) Section 8: Page 2 of 4
Alma Lasers Soprano Titanium
• 810 nm applicator
• 755 nm applicator
• Small NIR applicator
• Footswitch and other laser safety accessories
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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58786 | Dermatological diode laser system |
A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam designed to perform dermatological procedures such as body hair removal (e.g., armpit, leg/arm, back, chest, bikini line, and face) and/or skin resurfacing (e.g., treatment of benign lesions, wrinkle reduction). It is intended to be used by a trained professional to emit pulsed light of a specific wavelength (e.g., around 808 nm or 1060 nm), delivered by a dedicated handpiece. It typically includes a control unit with dedicated software and user interface, delivery handpiece, and footswitch.
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Active | false |
58935 | Intense pulsed light skin surface treatment system |
A mains electricity (AC-powered) mobile (on wheels) device designed to produce strong, controlled flashes of filtered light in the wavelength range 400 - 1200nm [intense pulsed light (IPL)] for heat ablation of pigmented skin cells (selective photothermolysis) to treat multiple skin/pigmentation conditions. The device typically enables variation of treatment parameters (wavelength, duration of impulses, single/multiple impulses) for treatment of conditions such as acne, telangiectasia, pigmentation (freckles, sun spots, liver spots) and/or for hair reduction. It consists of a control unit with user interface display and control panel, and a wire-connected applicator.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GEX | Powered Laser Surgical Instrument |
ILY | Lamp, Infrared, Therapeutic Heating |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K222064 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
fe8f1554-41ee-4af4-8453-d93f7c1e5bb3
June 19, 2023
2
November 06, 2022
June 19, 2023
2
November 06, 2022
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined