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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Analysis, Anterior Segment
510(k) Number K223700
Device Name BOSS™
Applicant
Intelon Optics, Inc.
331 Montvale Ave. Floor 5
Woburn,  MA  01801
Applicant Contact Pavana Mysore Ganesh
Correspondent
Intelon Optics, Inc.
331 Montvale Ave. Floor 5
Woburn,  MA  01801
Correspondent Contact Pavana Mysore Ganesh
Regulation Number886.1850
Classification Product Code
MXK  
Date Received12/12/2022
Decision Date 08/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Clinical Trials NCT05423041
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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