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SMARTPICO - Multi-modality skin surface treatment system - ARTG 395671

Access comprehensive regulatory information for SMARTPICO - Multi-modality skin surface treatment system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 395671 and sponsored by High Tech Medical Pty Ltd, manufactured by Deka M E L A Srl in Italy. The device registration started on September 08, 2022.

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
ARTG 395671
Class IIb
SMARTPICO - Multi-modality skin surface treatment system
ARTG ID: 395671
Good Name: High Tech Medical Pty Ltd - SMARTPICO - Multi-modality skin surface treatment system
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Intended Purpose

The SmartPico system is medical device indicated for treatment of benign pigmented lesions, tattoo removal, scar treatment, skin rejuvenation and toning. This laser system comes with a wide choice of emission modes, ranging from picosecond to hundreds of microseconds of pulse duration. The available sources are Nd:YAG lasers at 532 nm and 1064 nm, operating in single, or double Q-switched mode, and in the Picosecond pulse mode. The Q-switched laser at 1064 nm can also operate in "free running" mode, delivering pulses of hundreds of microseconds (Thermal pulse). The laser system comes supplied with different handpieces.

Device Classification
Risk Class
Class IIb
Product Type
Medical device system
ARTG Category
General
Registration Information
ARTG ID
395671
Start Date
September 08, 2022
Effective Date
September 08, 2022
Manufacturer
Country
Italy
Address
Via Baldanzese 17, Calenzano Firenze, FI, 50041