Cleared Special

NFC-600 Automated Portable Retinal Camera

K210197 · Crystalvue Medical Corporation · Ophthalmic

Apr 2021

Decision

78d

Days

Class 2

Risk

About This 510(k) Submission

K210197 is an FDA 510(k) clearance for the NFC-600 Automated Portable Retinal Camera, a Camera, Ophthalmic, Ac-powered (Class II — Special Controls, product code HKI), submitted by Crystalvue Medical Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on April 13, 2021, 78 days after receiving the submission on January 25, 2021. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1120.

Submission Details

510(k) Number	K210197 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 25, 2021
Decision Date	April 13, 2021
Days to Decision	78 days
Submission Type	Special
Review Panel	Ophthalmic (OP)
Summary	Summary PDF