Cleared Traditional

K134039 - DAYTONA ICG (P200TICG)

K134039 is an FDA 510(k) clearance for DAYTONA ICG (P200TICG), manufactured by Optos Plc.. The device is a Class 2 Ophthalmic device with product code MYC cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K134039 · Optos Plc. · Ophthalmic device
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Apr 2014
Decision
101d
Days
Class 2
Risk

K134039 is an FDA 510(k) clearance for the DAYTONA ICG (P200TICG). Classified as Ophthalmoscope, Laser, Scanning (product code MYC), Class II - Special Controls.

Submitted by Optos Plc. (Washington, US). The FDA issued a Cleared decision on April 11, 2014 after a review of 101 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 Optos Plc. devices

FDA 510(k) Submission Details - K134039

510(k) Number K134039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2013
Decision Date April 11, 2014
Days to Decision 101 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 110d · This submission: 101d
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 22
Devices cleared under the same product code (MYC) and FDA review panel - the closest regulatory comparables to K134039.
COMPASS
K150320 · Centervue S.P.A. · Jun 2015
P200DTx
K142897 · Optos Plc. · Jan 2015
EIDON
K142047 · Centervue S.P.A. · Nov 2014
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