510(k) K170302

YELLOW LASER PHOTOCOAGULATOR YLC-500 by Nidek Co., Ltd. — Product Code HQF

K170302 is an FDA 510(k) premarket notification submitted by Nidek Co., Ltd. for the device "YELLOW LASER PHOTOCOAGULATOR YLC-500". The FDA issued a decision of Substantially Equivalent on June 23, 2017. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Nidek Co., Ltd. has at least 10 other 510(k) clearances on record.