Precise LTM Diode Laser 002-00176

GUDID 00872320001360

Diode laser for dental soft tissue treatments and procedures.

CAO GROUP, INC.

Dental diode laser system

• Primary Device ID: 00872320001360
• NIH Device Record Key: f468b071-4594-4475-9869-7fef1ce9c008
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precise LTM Diode Laser
• Version Model Number: 002-00176
• Catalog Number: 002-00176
• Company DUNS: 102422578
• Company Name: CAO GROUP, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 877-236-4408
• Email: info@caogroup.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00872320001360 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062619

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-11-08
• Device Publish Date: 2016-11-10

Devices Manufactured by CAO GROUP, INC.

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• 00872320006464 - Acuity Direct X-Ray Photon Detection: 2024-02-27 Acuity Direct X-Ray Photon Detection sensor, which converts x-rays directly to a digital image without the use of a scintillator
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• 00872320005610 - Monet Curing Laser: 2020-12-22 Handheld laser device used for polymerizing dental materials.
• 00872320005627 - Monet Curing Laser Battery Pack: 2020-12-22 Replacement battery pack for use with the Monet Curing Laser.
• 00872320005634 - Monet Curing Laser Large Glasses: 2020-12-22 Large laser protective glasses for use with the Monet Curing Laser.
• 00872320005641 - Monet Curing Laser Small Glasses: 2020-12-22 Small laser protective glasses for use with the Monet Curing Laser.
• 00872320005665 - Monet Curing Laser Charging Stand: 2020-12-22 Replacement charging stand for use with the Monet Curing Laser.