truSculpt 3D RF Device

truSculpt 3D RF Device
truSculpt - truSculpt 2 MHz

An assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: GEI

Device Name: Electrosurgical, Cutting & Coagulation & Accessories

Device Class: 2

Physical State: N/A

Definition: Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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: 878.4400

Third Party Flag: Y

Medical Specialty: SU

Code: PBX

Device Name: Massager, Vacuum, Radio Frequency Induced Heat

Device Class: 2

Physical State: A console that generates the RF energy. It has two handpieces, an RF handpiece to apply energy for the pain relief indication and a mechanical roller handpiece for the cellulite indication.

Definition: Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Increases the temperature of skin by deposition of RF waves to relieve minor aches and pain. It uses a mechanical roller to reduce the appearance of cellulite.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Skin.

Regulation Number: 878.4400

Third Party Flag: Y

Medical Specialty: SU

Device Id: 00816722021410

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