truSculpt 3D RF Handpiece

truSculpt 3D RF Handpiece
truSculpt 3D - truSculpt 3D

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: GEX

Device Name: Powered Laser Surgical Instrument

Device Class: 2

Physical State: N/A

Definition: A laser (light amplification by stimulated emission of radiation) based device having coherence, collimated and typically monochromatic radiation. Typically indicated to to cut, destroy, remove or coagulate tissue, generally soft tissue, for general surgical purpose in medical specialties of general and plastic surgery, dermatology/aesthetic, podiatry, otolaryngology (ent), gynecology, neurosurgery, orthopedics (soft tissue), dental and oral surgery, and dentistry. The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, remove or coagulate tissue by the light.

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

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: 00816722022431

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