Cleared Traditional

Ophthalmic Yag Laser System YC-200

K203130 · Nidek Co., Ltd. · Ophthalmic
Dec 2020
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K203130 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 December 7, 2020, 49 days after receiving the submission on October 19, 2020. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4390.

Submission Details

510(k) Number K203130 FDA.gov
FDA Decision Cleared SESE
Date Received October 19, 2020
Decision Date December 07, 2020
Days to Decision 49 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