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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Tomography, Optical Coherence
510(k) Number K252633
Device Name UNITY DX (UDX)
Applicant
Cylite Pty. , Ltd.
300 Wellington Rd.
Mulgrave,  AU 3170
Applicant Contact Arnold Ouyang
Correspondent
Alcon Research, LLC
20511 Lake Forest Dr.
Lake Forest,  CA  92630
Correspondent Contact Michelle Ravert
Regulation Number886.1570
Classification Product Code
OBO  
Subsequent Product Code
HJO  
Date Received08/20/2025
Decision Date 12/23/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT06826599
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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