Cleared Traditional

YELLOW LASER PHOTOCOAGULATOR YLC-500

K170302 · Nidek Co., Ltd. · Ophthalmic
Jun 2017
Decision
143d
Days
Class 2
Risk

About This 510(k) Submission

K170302 is an FDA 510(k) clearance for the YELLOW LASER PHOTOCOAGULATOR YLC-500, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Nidek Co., Ltd. (Gamagori, JP). The FDA issued a Cleared decision on June 23, 2017, 143 days after receiving the submission on January 31, 2017. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K170302 FDA.gov
FDA Decision Cleared SESE
Date Received January 31, 2017
Decision Date June 23, 2017
Days to Decision 143 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQF — Laser, Ophthalmic
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.4390