Cleared Traditional

NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT

K133358 · Nidek Co., Ltd. · Ophthalmic

Aug 2014

Decision

285d

Days

Class 2

Risk

About This 510(k) Submission

K133358 is an FDA 510(k) clearance for the NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Nidek Co., Ltd. (Albignasego (Padova), IT). The FDA issued a Cleared decision on August 12, 2014, 285 days after receiving the submission on October 31, 2013. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number	K133358 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 31, 2013
Decision Date	August 12, 2014
Days to Decision	285 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF