DEVICE: Plus (07290016633245)
Device Identifier (DI) Information
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
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 |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
ISA | Massager, Therapeutic, Electric |
PBX | Massager, Vacuum, Radio Frequency Induced Heat |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K153568 | 000 |
Sterilization
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 |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
9680a3d1-50f9-441a-bc2c-bf9ca8cc634e
July 06, 2018
3
October 25, 2016
July 06, 2018
3
October 25, 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 |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
1-887-367-4556
contact@inmode.com
contact@inmode.com