FDA.report

510(k) K231222

Device
3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)
Applicant
Topcon Corporation
510(k) number
K231222
Product code
OBO
Decision
Substantially Equivalent (SESE)
Decision date
2023-10-30
Date received
2023-04-28
Regulation
886.1570
Classification name
Tomography, Optical Coherence
Medical specialty
Ophthalmic
Review panel
Ophthalmic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Ryota Kitawaki
Address
75-1 Hasunuma-Cho Itabashi-Ku JP 174-8580 174-8580

FDA Registration Numbers

Source Documents

510(k) summary PDF

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