Cleared Traditional

K111988 - EASYSCAN MODEL 1.2

K111988 is an FDA 510(k) clearance for EASYSCAN MODEL 1.2, manufactured by I-Optics BV. The device is a Class 2 Ophthalmic device with product code MYC cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K111988 · I-Optics BV · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2011
Decision
107d
Days
Class 2
Risk

K111988 is an FDA 510(k) clearance for the EASYSCAN MODEL 1.2. Classified as Ophthalmoscope, Laser, Scanning (product code MYC), Class II - Special Controls.

Submitted by I-Optics BV (Claremont, US). The FDA issued a Cleared decision on October 28, 2011 after a review of 107 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 I-Optics BV devices

FDA 510(k) Submission Details - K111988

510(k) Number K111988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2011
Decision Date October 28, 2011
Days to Decision 107 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
3d faster than avg
Panel avg: 110d · This submission: 107d
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 11
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