Cleared Traditional

K142897 - P200DTx

K142897 is an FDA 510(k) clearance for P200DTx, 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 105-day FDA review.

K142897 · Optos Plc. · Ophthalmic device
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Jan 2015
Decision
105d
Days
Class 2
Risk

K142897 is an FDA 510(k) clearance for the P200DTx. Classified as Ophthalmoscope, Laser, Scanning (product code MYC), Class II - Special Controls.

Submitted by Optos Plc. (Dunfermline, GB). The FDA issued a Cleared decision on January 16, 2015 after a review of 105 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 - K142897

510(k) Number K142897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2014
Decision Date January 16, 2015
Days to Decision 105 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
5d faster than avg
Panel avg: 110d · This submission: 105d
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 Consultant

Hogan Lovells US LLP
RANDY PREBULA

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 22
Devices cleared under the same product code (MYC) and FDA review panel - the closest regulatory comparables to K142897.
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EIDON
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DAYTONA ICG (P200TICG)
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