CAO GROUP, INC.

Address:4628 WEST SKYHAWK DRIVE,WEST JORDAN,UT,84084,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (10)

Premarket Exempt

No Yes

Clear

Precise SHP Display Stand - 00872320001803 Catalog Number : 002-00239

Device Description : Replacement display stand for use with the Precise SHP Diode Laser.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Precise SHP Display Stand - 00872320001810 Catalog Number : 002-00240

Device Description : Display stand for use with the Precise SHP Diode Laser.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Pioneer Pro Diode Laser - 00872320001872 Catalog Number : 002-00245

Device Description : Pioneer Pro Dental Diode Laser

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Precise SHP Diode Laser - 00872320001940 Catalog Number : 002-00255

Device Description : Precise SHP dental diode laser.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Precise SHP Whitening Cone - 00872320001964 Catalog Number : 002-00249

Device Description : Replacement whitening cone for use with the Precise SHP Diode Laser.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Pioneer Elite Diode Laser - 00872320002411 Catalog Number : 002-00244

Device Description : Pioneer Elite Diode Laser for dental soft-tissue treatment.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Pioneer Elite Battery Pack - 00872320002428 Catalog Number : 002-00258

Device Description : Replacement battery pack for use with the Pioneer Elite Diode Laser.

Device Class :

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Pioneer Elite Fiber Cable - 00872320002442 Catalog Number : 002-00264

Device Description : Replacement optical fiber cable for use with the Pioneer Elite Diode Laser.

Device Class :

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

Pioneer Laser Laser Protective Glasses - 00872320002459 Catalog Number : 002-00275

Device Description : Laser protective eyewear for use with the Pioneer family of diode lasers.

Device Class : 2

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

Pioneer Elite Therapy Handpiece - 00872320002473 Catalog Number : 002-00277

Device Description : Therapeutic treatment handpiece for use with the Pioneer Elite Diode Laser.

Device Class :

Duns Number: 102422578

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

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