Cleared Special

K021787 - VISUCAM (FDA 510(k) Clearance)

Class I Ophthalmic device.

K021787 · Carl Zeiss Ophthalmic Systems, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2002
Decision
22d
Days
Class 1
Risk

K021787 is an FDA 510(k) clearance for the VISUCAM. Classified as Device, Storage, Images, Ophthalmic (product code NFF), Class I - General Controls.

Submitted by Carl Zeiss Ophthalmic Systems, Inc. (Washington, US). The FDA issued a Cleared decision on June 21, 2002 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 892.2010 - 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 Carl Zeiss Ophthalmic Systems, Inc. devices

Submission Details

510(k) Number K021787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 30, 2002
Decision Date June 21, 2002
Days to Decision 22 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 110d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NFF Device, Storage, Images, Ophthalmic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.2010
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.