PerioLase VIII

GUDID D808VIII1

The PerioLase is a FR Nd:YAG laser producing laser emission at 1064nm with variable pulse durations. The laser consists of two interconnected sections: the cabinet which houses the laser head, the power supply, the cooling system and the microprocessor with control panel; and the fiber optic delivery system which includes the Fiberflex fiber and Trueflex handpiece.

MILLENNIUM DENTAL TECHNOLOGIES, INC.

General/multiple surgical solid-state laser system

• Primary Device ID: D808VIII1
• NIH Device Record Key: 16778ee5-5f40-49d1-b45e-87cf08f0726d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PerioLase
• Version Model Number: MVP-7
• Catalog Number: VIII
• Company DUNS: 062754457
• Company Name: MILLENNIUM DENTAL TECHNOLOGIES, 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 562-860-2908
• Email: jdematteo@lanap.com
• Phone: 562-860-2908
• Email: jdematteo@lanap.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D808VIII1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K030290

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-08-15