NORSELD PTY. LIMITED

Address:18 LOWE ST,ADELAIDE South Australia,AU

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (1)

Premarket Exempt

Clear

Copper Bromide Laser - B241D10B0 Catalog Number :

Device Description : The Dual Yellow laser is indicated for the treatment of benign pigmented and cut The Dual Yellow laser is indicated for the treatment of benign pigmented and cutaneous vascular lesions.The Dual Yellow laser, operating at 578 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous vascular lesions including but not limited to:Treatment of wrinkles, Periocular wrinkles, Periorbital wrinkles. Facial and leg telangiectasia, Rosacea, Cherry angiomas, Port wine stains, Hemangiomas and venous lakes, Angioma, Spider angioma, and Poikiloderma of Civatte, Inflammatory Acne Vulgaris, Verrucae/Warts, Scars, Striea, and Psoriasis.Podiatry - for benign cutaneous lesions and warts.The Dual Yellow lase, operating at 511 rn, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous pigmented lesions including but not limited to:Lentigines, Solar keratoses, Adenoma serabaceum, Skin tabs, Trichoepitheliomas (benign lesions similar to skin tags) Naevi, Keratoses, Syringomas Seborrhoeic keratoses Verrucae vulgaris, and Warts.

Device Class : 2

Duns Number: 756169231

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

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