Cleared Traditional

K112880 - CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE

K112880 is an FDA 510(k) clearance for CLEARPATH DS-120 LENS FLUORESCENCE BIOM..., manufactured by Freedom Meditech, Inc.. The device is a Class 2 Ophthalmic device with product code MYC cleared through the Traditional 510(k) pathway after a 489-day FDA review.

K112880 · Freedom Meditech, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2013
Decision
489d
Days
Class 2
Risk

K112880 is an FDA 510(k) clearance for the CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE. Classified as Ophthalmoscope, Laser, Scanning (product code MYC), Class II - Special Controls.

Submitted by Freedom Meditech, Inc. (San Diego, US). The FDA issued a Cleared decision on January 31, 2013 after a review of 489 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

FDA 510(k) Submission Details - K112880

510(k) Number K112880 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 2011
Decision Date January 31, 2013
Days to Decision 489 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
379d slower than avg
Panel avg: 110d · This submission: 489d
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.

K112880 · CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE
Download PDF FDA Summary Freedom Meditech, Inc.