BIOLASE, INC.

Address:4225 Prado Road,Corona,CA,92880,US

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Device Description : laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains laserwhite20 Whitening Gel contains 5 patient treatment kits. Each kit contains one syringe of whitening gel base, one syringe of gel activator, one syringe of liquid dam and one syringe of desensitizer. Accessories such as applicators are also included. The product is intended for use with Biolase diode lasers.

Device Class :

Duns Number: 152165700

Premarket Exempt : No

Product Code : LBH

Prescription Use : Yes

Device Count : 1

Device Description : A reusable handpiece intended for use with Diode Laser Systems and Diode Laser T A reusable handpiece intended for use with Diode Laser Systems and Diode Laser Tips in surgical soft tissue applications.

Device Class :

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Device Description : A surgical and therapeutic device intended for a variety of soft-tissue procedur A surgical and therapeutic device intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two handpieces and laser tips, a wireless footswitch and other accessories (power cords, protective eyewear, screen protectors, tip holders). The patient-contacting components of the delivery system require sterilization prior to use.

Device Class : 2

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Device Description : A surgical and therapeutic device intended for a variety of soft-tissue procedur A surgical and therapeutic device intended for a variety of soft-tissue procedures, laser-assisted tooth whitening and for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber cable, two surgical handpieces and laser tips, a wireless footswitch and other accessories (power cords, tip holders, protective eyewear, screen protectors). The patient-contacting components of the delivery system require sterilization prior to use.

Device Class : 2

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Device Description : A kit containing two (2) reusable surgical handpieces intended for use with Diod A kit containing two (2) reusable surgical handpieces intended for use with Diode Laser Systems and Diode Laser Tips in surgical soft-tissue applications.

Device Class :

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Device Description : Whitening Handpiece is intended for use with Biolase diode laser systems such as Whitening Handpiece is intended for use with Biolase diode laser systems such as Epic X or Epic Pro and LaserWhite20 Whitening Gel for laser-assisted tooth whitening procedures. The handpiece is reusable and requires disinfection prior to use. The handpiece is equipped with with single-use disposable protective shields included in the packaging in a set of 5.

Device Class :

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Device Description : A reusable topical heating device intended for use with Diode Laser Systems in p A reusable topical heating device intended for use with Diode Laser Systems in pain therapy. The device is used with disposable protective shields.

Device Class : 2

Duns Number: 152165700

Premarket Exempt : No

Product Code : ILY

Prescription Use : Yes

Device Count : 1

Device Description : A surgical and therapeutic device intended for a variety of soft tissue procedur A surgical and therapeutic device intended for a variety of soft tissue procedures as well as for use in providing temporary relief of minor pain. The system includes a laser console with a touch screen control panel/user interface, a wireless footswitch, a delivery system comprising of a fiber optic cable, two handpieces, and laser tips. Other system accessories include protective eyewear, power supply with power cords, screen protectors, and batteries. The patient-contacting components of the delivery system require sterilization prior to use.

Device Class : 2

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX, ILY

Prescription Use : Yes

Device Count : 1

Device Description : A therapeutic laser system intended for use in providing temporary relief of mi A therapeutic laser system intended for use in providing temporary relief of minor pain. The system contains a laser console, a fiberoptic delivery cable and a wireless footswitch. Other system accessories include protective eyewear, power supply with power cords, screen protectors and batteries.

Device Class : 2

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX, ILY

Prescription Use : Yes

Device Count : 1

Device Description : An all-tissue dental laser system intended for a variety of soft-tissue and hard An all-tissue dental laser system intended for a variety of soft-tissue and hard-tissue procedures. The system includes a laser console with a touch screen control panel/user interface, a delivery system comprising of a fiber optic cable, two handpieces and laser tips, a wired footswitch, and other accessories. The patient-contacting components of the delivery system require sterilization prior to use.

Device Class : 2

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1