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Home » Laseroptek Receives 510(k) Clearance for Its Helios IV-785 Laser System
Laseroptek Receives 510(k) Clearance for Its Helios IV-785 Laser System
Laseroptek has received 510(k) clearance from the FDA for its Helios IV-785 laser system for use in dermatology as well as general and plastic surgery.
The laser tool, which combines photoacoustic and thermal effects, is used to treat medical aesthetic indications across a wide range of Fitzpatrick skin types. The Fitzpatrick system categorizes skin according to how much melanin is present.
The Helios IV-785 system can be used for skin toning and brightening, removing benign pigmented and vascular lesions, and multi-color tattoos, the Korea-based company said.
Laseroptek is focused on developing medical devices for use in aesthetic and medical laser procedures.
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