- Physicians Office Resource

SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III
SA Med. Repl. Cover 25x30mm, 4Hr, Velashape III - AS83333

Device Description

An assembly of devices intended to use a combination of noninvasive energies and methods to locally reduce the subcutaneous fat layer, cellulite manifestation, and loose or wrinkled skin appearance. It consists of an electrically-powered control unit/generator to produce two or more energy modalities [e.g., radio-frequency, thermal/cryogenic (for cryolipolysis), high intensity focused ultrasound (HIFU), infrared light], and body-surface applicators to apply the treatment to the target area (e.g., chin, hips, abdomen, thighs); some types are additionally capable of applying vacuum.

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: 00817495024462

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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