Pioneer Pro Diode Laser 002-00245

GUDID 00872320001872

Pioneer Pro Dental Diode Laser

CAO GROUP, INC.

Dental diode laser system
Primary Device ID00872320001872
NIH Device Record Keyba109812-04e6-4bb1-8a36-883f61b72775
Commercial Distribution StatusIn Commercial Distribution
Brand NamePioneer Pro Diode Laser
Version Model Number002-00245
Catalog Number002-00245
Company DUNS102422578
Company NameCAO GROUP, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-236-4402
Emailinfo@pioneerlasers.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100872320001872 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-11-08
Device Publish Date2016-11-10

Devices Manufactured by CAO GROUP, INC.

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00872320005610 - Monet Curing Laser2020-12-22 Handheld laser device used for polymerizing dental materials.
00872320005627 - Monet Curing Laser Battery Pack2020-12-22 Replacement battery pack for use with the Monet Curing Laser.
00872320005634 - Monet Curing Laser Large Glasses2020-12-22 Large laser protective glasses for use with the Monet Curing Laser.
00872320005641 - Monet Curing Laser Small Glasses2020-12-22 Small laser protective glasses for use with the Monet Curing Laser.
00872320005665 - Monet Curing Laser Charging Stand2020-12-22 Replacement charging stand for use with the Monet Curing Laser.

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