Cleared Traditional

K051789 - VISANTE OCT

K051789 is the FDA 510(k) clearance for VISANTE OCT by Carl Zeiss Meditec, Inc.. It is a Class 2 Ophthalmic device (product code HLI) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K051789 · Carl Zeiss Meditec, Inc. · Ophthalmic device
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Sep 2005
Decision
91d
Days
Class 2
Risk

K051789 is an FDA 510(k) clearance for the VISANTE OCT. Classified as Ophthalmoscope, Ac-powered (product code HLI), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on September 30, 2005 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1570 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Carl Zeiss Meditec, Inc. devices

Submission Details

510(k) Number K051789 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2005
Decision Date September 30, 2005
Days to Decision 91 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 110d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HLI Ophthalmoscope, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
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 - HLI Ophthalmoscope, Ac-powered

All 21
Devices cleared under the same product code (HLI) and FDA review panel - the closest regulatory comparables to K051789.
VANTAGE INDIRECT OPHTHALMOSCOPE
K060822 · Keeler Instruments, Inc. · May 2006
WELCH ALLYN 11800 OPTHALMOSCOPE
K003376 · Welch Allyn, Inc. · Jan 2001
CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100
K992606 · Canon USA, Inc. · Jun 2000
HUMPHREY OCT SCANNER
K961171 · Carl Zeiss, Inc. · Jun 1996
WELCH ALLYN VIDEO OPHTHALMOSCOPE
K951210 · Welch Allyn, Inc. · Jun 1995
WELCH ALLYN OPHTHALMOSCOPE
K950461 · Welch Allyn, Inc. · Apr 1995