510(k) K233602

P200TE (A10700) by Optos Plc. — Product Code OBO

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 9, 2024
Date Received: November 9, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Tomography, Optical Coherence
Device Class: Class II
Regulation Number: 886.1570
Review Panel: OP
Submission Type

Viewing, imaging, measurement, and analysis of ocular structures. Diagnostic device to aid in the detection and management of various ocular diseases.

Other clearances by Optos Plc.

K231673 — P200TE (A10700) (August 18, 2023)
K190732 — P200TxE (July 31, 2019)
K173707 — P200TE (February 28, 2018)
K162039 — OptosAdvance 4.0 Software (February 8, 2017)
K142897 — P200DTx (January 16, 2015)
K134039 — DAYTONA ICG (P200TICG) (April 11, 2014)
K121043 — OPTOS OCT/SLO MICROPERIMETER (February 22, 2013)
K113696 — OPTOS ADVANCE (May 25, 2012)
K111628 — P200T (August 19, 2011)
K102492 — P200MAAF (September 30, 2010)

Other clearances for product code OBO

K252633 — UNITY DX (UDX) (December 23, 2025)
K250553 — Tomey Cornea/Anterior Segment OCT (CASIA2) (July 18, 2025)
K250868 — SPECTRALIS HRA+OCT and variants (May 12, 2025)
K240924 — Anterion (December 13, 2024)
K241163 — SPECTRALIS with Flex Module (October 11, 2024)
K241081 — 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic (July 17, 2024)
K240221 — SPECTRALIS HRA+OCT and variants (July 1, 2024)
K233933 — CIRRUS HD-OCT Model 6000 (May 17, 2024)
K233561 — 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) (April 10, 2024)
K233421 — RESCAN 700 (March 8, 2024)