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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Assisted Reproduction Laser
510(k) Number K202241
Device Name LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
Applicant
Hamilton Thorne, Inc.
100 Cummings Center
Suite 465e
Beverly,  MA  01915
Applicant Contact Donald Fournier
Correspondent
Hamilton Thorne, Inc.
100 Cummings Center
Suite 465e
Beverly,  MA  01915
Correspondent Contact Donald Fournier
Regulation Number884.6200
Classification Product Code
MRX  
Date Received08/10/2020
Decision Date 07/02/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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