Cleared Special

K040325 - PANORET, MODEL PNM 60

K040325 is an FDA 510(k) clearance for PANORET, manufactured by Medibell Medical Vision Technologies , Ltd.. The device is a Class 2 Ophthalmic device with product code HKI cleared through the Special 510(k) pathway after a 27-day FDA review.

K040325 · Medibell Medical Vision Technologies , Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2004
Decision
27d
Days
Class 2
Risk

K040325 is an FDA 510(k) clearance for the PANORET, MODEL PNM 60. Classified as Camera, Ophthalmic, Ac-powered (product code HKI), Class II - Special Controls.

Submitted by Medibell Medical Vision Technologies , Ltd. (Haifa, IL). The FDA issued a Cleared decision on March 8, 2004 after a review of 27 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 - K040325

510(k) Number K040325 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2004
Decision Date March 08, 2004
Days to Decision 27 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
83d faster than avg
Panel avg: 110d · This submission: 27d
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 K040325.
VISCUCAM C DIGITAL CAMERA
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DIGITAL FUNDUS CAMERA, MODEL CF-60DSI
K041546 · Canon, Inc. · Jun 2004
CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI
K031629 · Canon USA, Inc. · Jun 2003
MP-1 MICRO PERIMETER
K023719 · Nidek Technologies Srl · Dec 2002
FUNDUS AUTOIMAGER
K020888 · Visual Pathways, Inc. · Nov 2002
K040325 · PANORET, MODEL PNM 60
Download PDF FDA Summary Medibell Medical Visi…