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Radio-frequency skin surface treatment system applicator - ARTG 467812

Access comprehensive regulatory information for Radio-frequency skin surface treatment system applicator in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIb is registered under ARTG number 467812 and sponsored by SB Australia Trading Pty Ltd, manufactured by Bomtech Electronics Co Ltd in South Korea. The device registration started on November 08, 2024.

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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TGA ARTG Official Data
Class IIb
ARTG 467812
Class IIb
Radio-frequency skin surface treatment system applicator
ARTG ID: 467812
Good Name: SB Australia Trading Pty Ltd - Radio-frequency skin surface treatment system applicator
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Intended Purpose

The RF Surgical Equipment (RM STAR) is a non-sterile handpiece component of a radio- frequency skin surface treatment system used for the purpose of delivering a radio frequency to a patient through a needle for the coagulation of tissue for skin resurfacing, tissue regeneration and to improve the appearance of the skin. The radio frequency generated by the internal RF PCB of the device passes through the needles to skin. The RF emissions delivered over the whole dermal portion of the needles allow the heating of volume of tissue near their needles tips with a desired thermal effect, resulting in the effective coagulation to leave minimal-impact areas of skin to facilitate healing. This is a reusable device utilising a rechargeable battery with a USB charging cord.

Device Classification
Risk Class
Class IIb
Product Type
Single Device Product
ARTG Category
General
Registration Information
ARTG ID
467812
Start Date
November 08, 2024
Effective Date
November 08, 2024
Manufacturer
Country
South Korea
Address
322 Gonghang-Daero, Gangseo-Gu