Australian GovernmentDepartment of Health, Disability and AgeingTherapeutic Goods Administration Record Summary Sponsor Therapeutic Type Product Category ARTG Start Date Postal Address Billing Address 513685 Abmed Medical Technology Pty Ltd - Surgical frequency-doubled Nd:YAG laser system Abmed Medical Technology Pty Ltd Medical Device 38 Omar Street, Caulfield South, VIC, 3162 Australia 38 Omar Street, Caulfield South, VIC, 3162 Australia Medical Device - Class IIb - Included Active Medical Devices Product Type Status Approval Area - The inclusion of the kind of device in the ARTG is subject to compliance with all conditions placed or imposed on the ARTG entry. Refer Part 4-5, Division 2 (Conditions) of the Therapeutic Goods Act 1989 and Part 5, Division 5.2 (Conditions) of the Therapeutic Goods (Medical Devices) Regulations 2002 for relevant information. - Breaching conditions of the inclusion related to the device of the kind may lead to suspension or cancellation of the ARTG entry; may be a criminal offence; and civil penalties may apply. Room 7-201 No 1 Caida 3rd Street Nancai Town Shunyi District, Beijing , 101300 China Beijing Sano Laser S&T Development Co Ltd Certificate number(s) 1 . Surgical frequency-doubled Nd:YAG laser system Product Type Single Device Product Status Current GMDN 36150 Surgical frequency-doubled Nd:YAG laser system Functional Not included on record Intended Purpose The Q-Swithched Nd:YAG Laser is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision,ablation, vaporization of soft tissue for for General Dermatology, Dermatologic and General Surgical Procedures as follows: -Tattoo removal dark ink: blue and black -Treatment of Benign Pigmented Lesions -Tattoo removal Light ink: red, sky blue and green. -Treatment of benign vascular lesions Port wine birthmarks;Telangiectasias;Spider angioma;Cherry angioma;Spider nevi. -Treatment of benign pigmented lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi;Freckles; Nevus spilus. Record Summary Variant Information Device Information 04 Electro mechanical medical devices Specific Conditions No Specific Conditions included on Record Page 1 of 1 Produced at 09.10.2025 at 12:42:43 AEDT The details contained in this copy of the Record Summary reflect the information held at the nominated date and time of printing The currency and accuracy of the details can be confirmed at www.ebs.gov.au.