Cleared Traditional

K093521 - GDXPRO

K093521 is the FDA 510(k) clearance for GDXPRO by Carl Zeiss Meditec, Inc.. It is a Class 2 Ophthalmic device (product code MYC) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K093521 · Carl Zeiss Meditec, Inc. · Ophthalmic device
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Nov 2009
Decision
12d
Days
Class 2
Risk

K093521 is an FDA 510(k) clearance for the GDXPRO. Classified as Ophthalmoscope, Laser, Scanning (product code MYC), Class II - Special Controls.

Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on November 25, 2009 after a review of 12 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Carl Zeiss Meditec, Inc. devices

Submission Details

510(k) Number K093521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2009
Decision Date November 25, 2009
Days to Decision 12 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 110d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code MYC Ophthalmoscope, Laser, Scanning
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.