Cleared Traditional

P200TxE (K190732) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K190732 · Optos Plc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Jul 2019
Decision
132d
Days
Class 2
Risk

K190732 is an FDA 510(k) clearance for the P200TxE. Classified as Tomography, Optical Coherence (product code OBO), Class II - Special Controls.

Submitted by Optos Plc. (Dunfermline, GB). The FDA issued a Cleared decision on July 31, 2019 after a review of 132 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

Submission Details

510(k) Number K190732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 2019
Decision Date July 31, 2019
Days to Decision 132 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
22d slower than avg
Panel avg: 110d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OBO Tomography, Optical Coherence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1570
Definition Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - OBO Tomography, Optical Coherence

All 34
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