DEVICE: CoolLipoTM (04059497000723)
Device Identifier (DI) Information
CoolLipoTM
CL 500 S
In Commercial Distribution
M210608S
LEONI Fiber Optics GmbH
CL 500 S
In Commercial Distribution
M210608S
LEONI Fiber Optics GmbH
No description.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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No | |
Yes | |
Yes | |
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? |
---|---|---|---|---|
60341 | General/multiple surgical diode laser system |
An electrically-powered device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate tissues for general surgery and/or multiple specialized surgical applications (non-dedicated) such as lipolysis, endovenous laser therapy (EVLT), percutaneous laser disc decompression (PLDD), benign prostatic hyperplasia (BPH) therapy, and ear/nose/throat (ENT) interventions. It includes a diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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GEX | Powered laser surgical instrument |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K050738 | 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
33139de2-393e-4a00-aa2f-b78c9543f417
April 07, 2021
4
September 29, 2016
April 07, 2021
4
September 29, 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 |
---|---|---|---|---|---|
04059497000747 | 2 | 04059497000730 | In Commercial Distribution | ||
04059497000730 | 5 | 04059497000723 | In Commercial Distribution |
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