DEVICE: FRF (17290016633150)

Device Identifier (DI) Information

FRF
AG602426A
In Commercial Distribution
AG602426A
INMODE M.D LTD
17290016633150
GS1

5
600417351 *Terms of Use
Fractora 24P
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
Yes
No
No
No
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?
58454 Radio-frequency skin surface treatment system
An assembly of devices designed to apply radio-frequency (RF) energy to heat the skin surface for ablation, coagulation, and tightening of the skin’s outer later (stratum corneum) for aesthetic skin resurfacing. It primarily consists of a mains electricity (AC-powered) control unit to produce and regulate the RF energy, and a connected bipolar RF applicator (handpiece) to deliver the RF energy to the skin surface; the applicator may include vacuum to facilitate its coupling with the skin.
Obsolete false
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FDA Product Code

[?]
Product Code Product Code Name
GEI Electrosurgical, Cutting & Coagulation & Accessories
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K151273 000
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Sterilization

No
Yes
Sterilization Method [?]
Dry Heat Sterilization
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -20 and 65 Degrees Celsius
Storage Environment Humidity: between 0 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 110 KiloPascal
Handling Environment Temperature: between 15 and 30 Degrees Celsius
Handling Environment Humidity: between 30 and 80 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 90 and 110 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

de2cf843-800f-436a-9f80-786ebb0a6f72
July 06, 2018
3
October 25, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 07290016633153 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
1-887-367-4556
contact@inmode.com
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