Cleared Special

K052268 - VISUCAM PRO NM

K052268 is the FDA 510(k) clearance for VISUCAM PRO NM by Carl Zeiss Meditec, AG. It is a Class 2 Ophthalmic device (product code HKI) cleared through the Special 510(k) pathway after a 75-day FDA review.

K052268 · Carl Zeiss Meditec, AG · Ophthalmic device
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Nov 2005
Decision
75d
Days
Class 2
Risk

K052268 is an FDA 510(k) clearance for the VISUCAM PRO NM. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, AG (Dublin, US). The FDA issued a Cleared decision on November 2, 2005 after a review of 75 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 Carl Zeiss Meditec, AG devices

Submission Details

510(k) Number K052268 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2005
Decision Date November 02, 2005
Days to Decision 75 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
35d faster than avg
Panel avg: 110d · This submission: 75d
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 58
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K052268.
DIGITAL RETINAL CAMERA, CR-1 MARK II
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CF-1
K063717 · Canon, Inc. · Jan 2007
VISCUCAM C DIGITAL CAMERA
K043222 · Carl Zeiss Meditec, AG · Feb 2005
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K041546 · Canon, Inc. · Jun 2004
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
K031629 · Canon USA, Inc. · Jun 2003