Cleared Traditional

GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES (K093213) - FDA 510(k) Clearance

Class I Ophthalmic device.

K093213 · Carl Zeiss Meditec, Inc. · Ophthalmic device
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Mar 2010
Decision
150d
Days
Class 1
Risk

K093213 is an FDA 510(k) clearance for the GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES. Classified as Perimeter, Automatic, Ac-powered (product code HPT), Class I - General Controls.

Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on March 12, 2010 after a review of 150 days - an extended review cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1605 - 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 K093213 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 2009
Decision Date March 12, 2010
Days to Decision 150 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
40d slower than avg
Panel avg: 110d · This submission: 150d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code HPT Perimeter, Automatic, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 886.1605
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.