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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K243014
Device Name EyeQ nanoECP
Applicant
Eyeq, Inc.
8740 Technology Way
Suite 200
Reno,  NV  89521
Applicant Contact Gary Mocnik
Correspondent
Eyeq, Inc.
8740 Technology Way
Suite 200
Reno,  NV  89521
Correspondent Contact Gary Mocnik
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
MPA  
Date Received09/27/2024
Decision Date 06/18/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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