Cleared Special

K052268 - VISUCAM PRO NM

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

K052268 · Carl Zeiss Meditec, AG · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K052268

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.

HKI Device Classification - Class 2, Special Controls

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 156
Devices cleared under the same product code (HKI) and FDA review panel - the closest regulatory comparables to K052268.
OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5
K053044 · Opto Global, Inc. · Jan 2006
KOWA NONMYD 7, KOWA NONMYD A-D
K053026 · Kowa Co. , Ltd. · Nov 2005
KOWA GENESIS-D HAND-HELD RETINAL CAMERA
K050271 · Kowa Co. , Ltd. · Nov 2005
KOWA VX-10
K043213 · Kowa Co. , Ltd. · Oct 2005
VISCUCAM C DIGITAL CAMERA
K043222 · Carl Zeiss Meditec, AG · Feb 2005
TOPCON MODEL TRC-NW200 NON-MYDRIATIC RETINAL CAMERA
K041367 · Topcon Corp. · Nov 2004
K052268 · VISUCAM PRO NM
Download PDF FDA Summary Carl Zeiss Meditec, AG