Genesis Plus 1 mm Spot Size Adapter

Genesis Plus 1 mm Spot Size Adapter
Genesis Plus 1 mm Spot Size Adapter - Genesis Plus 1 mm Spot Size Adapter

A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod, or a fibre doped with a glass/crystal element (known as fibre laser), to emit a high-power laser beam intended to incise, excise, ablate, and vaporize soft tissues for dermatological applications such as skin resurfacing, acne treatment, and/or lesion/hair/tattoo removal; some types may also be used for coagulation/haemostasis procedures. It typically includes a light source, laser beam delivery/positioning device(s), user interface, and controls/foot-switch; it does not include frequency-doubling technology.

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No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: PDZ

Device Name: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

Device Class: 2

Physical State: Laser device outputting energy at different wavelengths

Definition: For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

Submission Type ID: 1

Review Panel: SU

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Laser energy delivered to the target area by scanning

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Toe nail of the patients with onychomycosis

Regulation Number: 878.4810

Third Party Flag: N

Medical Specialty: SU

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

Device Id: 00816722023209

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