DEVICE: Vela SA applicator (07290109951348)
Device Identifier (DI) Information
Vela SA applicator
AS38211R
Not in Commercial Distribution
AS38211R
SYNERON MEDICAL LTD
AS38211R
Not in Commercial Distribution
AS38211R
SYNERON MEDICAL LTD
Vela SA Appl.Pack.+ Disp.Parts for Appl.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
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No | |
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No |
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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44832 | Multi-modality skin contouring system |
An assembly of devices that uses a combination of energies to temporarily minimize the manifestation of cellulite and loose or wrinkled skin. It typically consists of an applicator attached to an energy-producing generator and possibly other components. The applicator is applied to the body and may emit radio-frequency [typically in the bands of 1 megahertz (MHz)], infrared light, and/or other forms of energy, to heat skin/subdermal tissues for the production of a smooth-skin appearance. Vacuum may also be included.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NUV | Massager, Vacuum, Light Induced Heating |
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
d5446045-51f0-4cd1-b177-f3babfa7cb3b
June 22, 2023
4
September 22, 2016
June 22, 2023
4
September 22, 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
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined