Cleared Special

NFC-600 Automated Portable Retinal Camera (K210197) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K210197 · Crystalvue Medical Corporation · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2021
Decision
78d
Days
Class 2
Risk

K210197 is an FDA 510(k) clearance for the NFC-600 Automated Portable Retinal Camera. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Crystalvue Medical Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on April 13, 2021 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1120 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Crystalvue Medical Corporation devices

Submission Details

510(k) Number K210197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 110d · This submission: 78d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HKI Camera, Ophthalmic, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HKI Camera, Ophthalmic, Ac-powered

All 34
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