P200TxE

FDA 510(k) K190732 · Optos Plc.

Substantially Equivalent

510(k) numberK190732

Submission

Device name
P200TxE
Applicant
Optos Plc.
Dunfermline, GB
Received
March 21, 2019
Decision date
July 31, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
OBO – Tomography, Optical Coherence
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1570
Specialty
Ophthalmic

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

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K2410813D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data…OBO · Traditional Topcon Corporation07/17/2024SE
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More from Carl Zeiss Meditec, Inc.

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K173707P200TEOBO · Traditional 02/28/2018SE
K162039OptosAdvance 4.0 SoftwareNFJ · Traditional 02/08/2017SE
K142897P200DTxMYC · Traditional 01/16/2015SE
K134039Daytona Icg (P200TICG)MYC · Traditional 04/11/2014SE
K121043Optos Oct/Slo MicroperimeterOBO · Traditional 02/22/2013SE
K113696Optos AdvanceNFJ · Traditional 05/25/2012SE
K111628P200TMYC · Special 08/19/2011SE
K102492P200MAAFMYC · Special 09/30/2010SE

Questions and answers

When was P200TxE cleared by the FDA?

P200TxE (K190732) received a 510(k) decision of Substantially Equivalent on July 31, 2019, 132 days after the submission was received.

What is the product code of K190732?

The FDA product code is OBO – Tomography, Optical Coherence, a Class II (moderate risk) device regulated under 21 CFR 886.1570.