Bendable disposable tips for use with AMD LASERS' Picasso Line of soft-tissue dental lasers. Contains twenty-five (25) tips of 300um core diameter, 10mm fiber length, and are bent to 60 degree angle.

Bendable disposable tips for use with AMD LASERS' Picasso Line of soft
Bendable Disposable Tips (Box of 25) 300um, 60 degree, 10mm - TIP3006010

Device Description

A mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam intended to cut, excise, vaporize, and coagulate oral tissues in various dental applications such as oral soft-tissue surgery, gingivectomy, to diminish inflammation, and for oral therapy and tooth whitening; it is not a dedicated tooth-bleaching acceleration unit. It includes a portable diode laser light source, flexible fibreoptic delivery cable, and controls/foot-switch; it may include a rechargeable battery.

Environmental Conditions

No Data Available

Device Sizes

Length: 10 Millimeter

Outer Diameter: 300 Micrometer

Angle: 60 degree

Length: 10 Millimeter
Outer Diameter: 300 Micrometer
Angle: 60 degree

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

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 Identifiers

Device Id: 00851759007068

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