FDA.report

510(k) K252633

Device
UNITY DX (UDX)
Applicant
Cylite Pty. , Ltd.
510(k) number
K252633
Product code
OBO
Decision
Substantially Equivalent (SESE)
Decision date
2025-12-23
Date received
2025-08-20
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
N

Related Records

Applicant Contact

Contact
Arnold Ouyang
Address
300 Wellington Rd. Mulgrave AU 3170 3170

FDA Registration Numbers

Source Documents

510(k) summary PDF

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