Precise Lasers Overfit-Style Glasses 002-00268

GUDID 00872320003494

Laser protective eyewear for use with the Precise family of diode lasers.

CAO GROUP, INC.

Radiation shielding goggles/spectacles

• Primary Device ID: 00872320003494
• NIH Device Record Key: a8eef913-7261-45d0-bda1-3620f3ed9e53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Precise Lasers Overfit-Style Glasses
• Version Model Number: 002-00268
• Catalog Number: 002-00268
• Company DUNS: 102422578
• Company Name: CAO GROUP, INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: false
• 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@preciselasers.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00872320003494 [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: 2019-05-23
• Device Publish Date: 2016-11-10

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