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Phototherapy unit, red light, line-powered - ARTG 328245

Access comprehensive regulatory information for Phototherapy unit, red light, line-powered in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is registered under ARTG number 328245 and sponsored by Kevin Grundy (IBD) Pty Ltd, manufactured by Espansione Marketing SpA in Italy. The device registration started on January 03, 2020.

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 IIa
ARTG 328245
Class IIa
Phototherapy unit, red light, line-powered
ARTG ID: 328245
Good Name: Kevin Grundy (IBD) Pty Ltd - Phototherapy unit, red light, line-powered
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Intended Purpose

Intended for the endogenous heating of the eyelids using LED light technology (LLLT) for the treatment of dry eye syndrome. Also intended for application of LED light to the scalp for the treatment of Androgenetic Alopecia in combination with other therapies (plasma) and Telogen effluvium in combination with laser therapy.

Device Classification
Risk Class
Class IIa
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
328245
Start Date
January 03, 2020
Effective Date
January 03, 2020
Manufacturer
Country
Italy
Address
Blocco 27 Via degli Orefeci 152, Centergross BO, Funo, 40050