LYKOS Assisted Reproduction Laser With Dynamic Targeting System (DTS)

System, Assisted Reproduction Laser

Hamilton Thorne, Inc.

The following data is part of a premarket notification filed by Hamilton Thorne, Inc. with the FDA for Lykos Assisted Reproduction Laser With Dynamic Targeting System (dts).

Pre-market Notification Details

Device IDK202241
510k NumberK202241
Device Name:LYKOS Assisted Reproduction Laser With Dynamic Targeting System (DTS)
ClassificationSystem, Assisted Reproduction Laser
Applicant Hamilton Thorne, Inc. 100 Cummings Center, Suite 465E Beverly,  MA  01915
ContactDonald Fournier
CorrespondentDonald Fournier
Hamilton Thorne, Inc. 100 Cummings Center, Suite 465E Beverly,  MA  01915
Product CodeMRX  
CFR Regulation Number884.6200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-08-10
Decision Date2021-07-02

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