Hygea Diode Laser

GUDID 00872320004699

Diode laser for soft tissue treatment procedures in the oral cavity

CAO GROUP, INC.

Dental diode laser system
Primary Device ID00872320004699
NIH Device Record Key6764a06f-3fa2-4ce3-bdb6-e693c1d85c8e
Commercial Distribution StatusIn Commercial Distribution
Brand NameHygea Diode Laser
Version Model Number04778
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

Phone866-999-2635
Emailsupport@amdlasers.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100872320004699 [Package]
Contains: 00872320004842
Package: Kit [1 Units]
In Commercial Distribution
GS100872320004842 [Primary]

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-11
Device Publish Date2019-12-03

Devices Manufactured by CAO GROUP, INC.

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00872320006464 - Acuity Direct X-Ray Photon Detection2024-02-27 Acuity Direct X-Ray Photon Detection sensor, which converts x-rays directly to a digital image without the use of a scintillator
00872320006471 - Hubble Digital Vision2024-01-30 Battery powered electronic magnification loupe and display system for use in clinical settings.
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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