DEVICE: U-Sculpt Power Transducer, (07290109952147)
Device Identifier (DI) Information
U-Sculpt Power Transducer,
FG71531
Not in Commercial Distribution
FG71531
SYNERON MEDICAL LTD
FG71531
Not in Commercial Distribution
FG71531
SYNERON MEDICAL LTD
U-Sculpt Power Transducer, Packaged, UltraShape Power
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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45591 | Ultrasonic body contouring system |
An assembly of devices intended for the transdermal application of ultrasonic energy to rupture targeted fat cells in areas where they tend to enlarge (e.g., hips, thighs, abdomen, buttocks), to reshape those areas for cosmetic purposes. The assembly typically consists of a mains electricity (AC-powered) ultrasonic energy generator with user controls/interface and an ultrasonic transducer used to transmit the energy to a target area to emulsify fat cells; it may include a video imaging system that takes into account real-time body movement to precisely position the transducer during treatment. The use of this system may serve as a noninvasive outpatient procedure alternative to liposuction.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
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
8be13e21-00ee-40ca-ae0f-1248a35cc1b9
June 22, 2023
4
September 26, 2016
June 22, 2023
4
September 26, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
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