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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Labware, Assisted Reproduction
510(k) Number K262066
Device Name Pleiades Device
Applicant
My123Baby Medical Limited Dba Boost Fertility
Werinherstr. 3
Munich,  DE 81541
Applicant Contact Daniel Wilson
Correspondent
Proxima CRO
2450 Holocombe Blvd.
Houston,  TX  77021
Correspondent Contact Carmen Brown
Regulation Number884.6160
Classification Product Code
MQK  
Date Received06/22/2026
Decision Date 10/30/2026
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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