P200TE (A10700)— 510(k) K233602

Substantially Equivalent

Optos Plc.

FDA 510(k) clearance K233602 for P200TE (A10700), Substantially Equivalent on 2024-05-09. Applicant: Optos Plc.. Device class: 2.

Clearance details

Applicant: Optos Plc.
Product code: Code OBO
Device class: Class 2
Regulation: 21 CFR 886.1570
Advisory panel: Ophthalmic
Date received: 2023-11-09
Decision date: 2024-05-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dunfermline, GB

Download summary PDF View on FDA.gov ↗

Recent devices under product code OBO

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K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2)2025-07-18
K250868 — SPECTRALIS HRA+OCT and variants2025-05-12

More clearances from Optos Plc.

K231673 — P200TE (A10700)2023-08-18
K190732 — P200TxE2019-07-31
K173707 — P200TE2018-02-28
K162039 — OptosAdvance 4.0 Software2017-02-08
K142897 — P200DTx2015-01-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.