Cleared Traditional

K093521 - GDXPRO

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

K093521 · Carl Zeiss Meditec, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K093521

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
Combination Product No
PCCP Authorized No
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.

MYC Device Classification - Class 2, Special Controls

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.

Regulatory Consultant

Underwriters Laboratories, Inc.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MYC Ophthalmoscope, Laser, Scanning

All 18
Devices cleared under the same product code (MYC) and FDA review panel - the closest regulatory comparables to K093521.
CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE
K112880 · Freedom Meditech, Inc. · Jan 2013
EASYSCAN MODEL 1.2
K111988 · I-Optics BV · Oct 2011
P200T
K111628 · Optos Plc. · Aug 2011
GDX VCC WITH ECC SOFTWARE
K082016 · Carl Zeiss Meditec, Inc. · Aug 2009
KOWA, FM-600, MODEL LSS50
K091039 · Kowa Co. , Ltd. · Aug 2009
OPHTHALMOSCOPE F-10
K072259 · Nidek Co., Ltd. · May 2008