Cleared Traditional

NIDEK MODEL GYC-1500 AND GYC-2000

K951079 · Nidek, Inc. · Ophthalmic
Sep 1995
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K951079 is an FDA 510(k) clearance for the NIDEK MODEL GYC-1500 AND GYC-2000, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Nidek, Inc. (Fremont, US). The FDA issued a Cleared decision on September 14, 1995, 189 days after receiving the submission on March 9, 1995. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K951079 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1995
Decision Date September 14, 1995
Days to Decision 189 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement

Device Classification

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