Cleared Traditional

K082016 - GDX VCC WITH ECC SOFTWARE

K082016 is an FDA 510(k) clearance for GDX VCC WITH ECC SOFTWARE, 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 391-day FDA review.

K082016 · Carl Zeiss Meditec, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2009
Decision
391d
Days
Class 2
Risk

K082016 is an FDA 510(k) clearance for the GDX VCC WITH ECC SOFTWARE. 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 August 10, 2009 after a review of 391 days - an unusually long review period, suggesting complex equivalence evaluation.

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

FDA 510(k) Submission Details - K082016

510(k) Number K082016 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2008
Decision Date August 10, 2009
Days to Decision 391 days
Submission Type Traditional
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
281d slower than avg
Panel avg: 110d · This submission: 391d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - MYC Ophthalmoscope, Laser, Scanning

All 23
Devices cleared under the same product code (MYC) and FDA review panel - the closest regulatory comparables to K082016.
P200MAAF
K102492 · Optos Plc. · Sep 2010
OPTOS LIMITED PANORAMIC 200CAF
K100644 · Optos Plc. · Jul 2010
GDXPRO
K093521 · Carl Zeiss Meditec, Inc. · Nov 2009
KOWA, FM-600, MODEL LSS50
K091039 · Kowa Co. , Ltd. · Aug 2009
OPHTHALMOSCOPE F-10
K072259 · Nidek Co., Ltd. · May 2008
PANORAMIC, MODEL 200MA
K060424 · Optos Plc. · Mar 2006
K082016 · GDX VCC WITH ECC SOFTWARE
Download PDF FDA Summary Carl Zeiss Meditec, I…