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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 K250868
Device Name SPECTRALIS HRA+OCT and variants
Applicant
Heidelberg Engineering GmbH
Max-Jarecki-Str. 8
Heidelberg,  DE 69115
Applicant Contact Arianna Schoess Vargas
Correspondent
Orasi Consulting, LLC.
226 1st Street
Bonita Springs,  FL  34134
Correspondent Contact Lena Sattler
Regulation Number886.1570
Classification Product Code
OBO  
Date Received03/24/2025
Decision Date 05/12/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT04604002
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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