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510(k) K250618

Medi Lift Essential Eye Mask by Ya-Man, Ltd. — Product Code NFO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 2025
Date Received
February 28, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

Other clearances by Ya-Man, Ltd.

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  • K220198 — Medi Lift PLUS (June 28, 2023)
  • K112016 — L-SER KO LAMP (February 10, 2012)
  • K032944 — YA-MAN LASER 21 (December 19, 2003)
  • K011021 — LASER 20 (October 9, 2001)

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