Pleiades Device— 510(k) K262066

Name: FDA 510(k) clearance K262066
Creator: U.S. Food and Drug Administration
Published: 2026-10-30

Substantially Equivalent

My123Baby Medical Limited Dba Boost Fertility

FDA 510(k) clearance K262066 for Pleiades Device, Substantially Equivalent on 2026-10-30. Applicant: My123Baby Medical Limited Dba Boost Fertility. Device class: 2.

Clearance details

Applicant: My123Baby Medical Limited Dba Boost Fertility
Product code: Product code MQK
Device class: Class 2
Regulation: 21 CFR 884.6160
Advisory panel: Obstetrics/Gynecology
Date received: 2026-06-22
Decision date: 2026-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Munich, DE

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.