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Waterlase - Dental solid-state laser system

Access comprehensive regulatory information for Waterlase - Dental solid-state laser system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is sponsored by Medilase, manufactured by Biolase Inc in United States of America. The device registration started on February 23, 2023.

This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.

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Class IIb
Class IIb
Waterlase - Dental solid-state laser system
Australia TGA ARTG Registered Device
Good Name: Medilase - Waterlase - Dental solid-state laser system
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Intended Purpose

A solid-state laser used to cut, shave, contour, roughen, etch and reset oral hard tissues and direct laser energy to perform oral soft tissue incision, excision, ablation and coagulation.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
Start Date
February 23, 2023
Effective Date
February 23, 2023
Sponsor
Manufacturer
Country
United States of America
Address
27042 Towne Centre Drive Foothill Ranch, CA, 92610