SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape III


Product Overview

SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5
SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape III - KT75672


Device Description

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.


Environmental Conditions

No Data Available


Device Sizes

No Data Available


Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available


Product Codes

Code: NUV

Device Name: Massager, Vacuum, Light Induced Heating

Device Class: 2

Physical State: N/A

Definition: THE DEVICE IS INTENDED TO TEMPORARILY ALTER THE APPEARANCE OF CELLULITE

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 878.4810

Third Party Flag: Y

Medical Specialty: SU


Device Identifiers

Device Id: 00817495024578

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A


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