Cleared Traditional

K231673 - P200TE (A10700) (FDA 510(k) Clearance)

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

K231673 · Optos Plc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2023
Decision
71d
Days
Class 2
Risk

K231673 is an FDA 510(k) clearance for the P200TE (A10700). 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 August 18, 2023 after a review of 71 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Optos Plc. devices

Submission Details

510(k) Number K231673 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 2023
Decision Date August 18, 2023
Days to Decision 71 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
39d faster than avg
Panel avg: 110d · This submission: 71d
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.

Clinical Evidence

ClinicalTrials.gov
NCT05624593 Unknown Interventional Industry-sponsored

P200TE and Predicate Agreement and Precision Study

P200TE Agreement and Precision Study

125
Patients (est.)
1
Site
Diagnostic
Purpose
Open label
Masking
Condition studied Normal; Retina Disease; Glaucoma
Study design Single group
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Sponsor Optos, PLC (industry)
Started 2022-11-04 → Primary completion 2023-03-01
Primary outcome
Limit of Agreement (LOA) between the P200TE and predicate device measurements of full retinal thickness.
View full study on ClinicalTrials.gov

Regulatory Peers - OBO Tomography, Optical Coherence

All 64
Devices cleared under the same product code (OBO) and FDA review panel - the closest regulatory comparables to K231673.
UNITY DX (UDX)
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SPECTRALIS HRA+OCT and variants
K250868 · Heidelberg Engineering GmbH · May 2025
Anterion
K240924 · Heidelberg Engineering GmbH · Dec 2024
SPECTRALIS with Flex Module
K241163 · Heidelberg Engineering GmbH · Oct 2024
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2)
K241081 · Topcon Corporation · Jul 2024