Cleared Traditional

Green Laser Photocoagulator GYC-500

K152603 · Nidek Co., Ltd. · Ophthalmic
May 2016
Decision
234d
Days
Class 2
Risk

About This 510(k) Submission

K152603 is an FDA 510(k) clearance for the Green Laser Photocoagulator GYC-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 May 2, 2016, 234 days after receiving the submission on September 11, 2015. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K152603 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2015
Decision Date May 02, 2016
Days to Decision 234 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