BIOLASE, INC.

Address:27042 Towne Centre Drive,Foothill Ranch,CA,92610,US

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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

Device Description : A non-sterile, single-use fiberoptic tip accessory intended for use with Biolase A non-sterile, single-use fiberoptic tip accessory intended for use with Biolase diode laser systems.

Device Class :

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Device Description : A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.

Device Class : 2

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Device Description : A non-sterile, single-use fiberoptic laser tip intended for use with Biolase dio A non-sterile, single-use fiberoptic laser tip intended for use with Biolase diode laser systems.

Device Class : 2

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Device Description : A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.

Device Class : 2

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Device Description : A single-use fiberoptic laser tip intended for use with Biolase diode laser systems.

Device Class :

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

- Catalog Number : 7410002

Device Description : A single-use non-sterile fiberoptic laser tip intended for use with Biolase diod A single-use non-sterile fiberoptic laser tip intended for use with Biolase diode laser systems.

Device Class : 2

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Device Description : A non-sterile, single-use fiberoptic laser tip intended for use with Biolase dio A non-sterile, single-use fiberoptic laser tip intended for use with Biolase diode laser systems.

Device Class : 2

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Device Description : A tip starting kit containing 22 different laser tips, intended for use with Wat A tip starting kit containing 22 different laser tips, intended for use with Waterlase laser delivery systems. The tips vary in type, length and core diameter.

Device Class : 2

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Device Description : A non-sterile single-use laser tip intended for use with Epic surgical diode las A non-sterile single-use laser tip intended for use with Epic surgical diode laser systems such as Epic S-Series.

Device Class : 2

Duns Number: 152165700

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1