Cleared Traditional

Ophthalmic Yag Laser System YC-200

K192045 · Nidek Co., Ltd. · Ophthalmic
Nov 2019
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K192045 is an FDA 510(k) clearance for the Ophthalmic Yag Laser System YC-200, a Laser, Ophthalmic (Class II — Special Controls, product code HQF), submitted by Nidek Co., Ltd. (Gamagori, JP). The FDA issued a Cleared decision on November 15, 2019, 107 days after receiving the submission on July 31, 2019. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K192045 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2019
Decision Date November 15, 2019
Days to Decision 107 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