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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Microneedle Device
510(k) Number K253002
Device Name SkinStylus SteriLock MicroSystem (MP1209SL)
Applicant
Esthetic Medical, Inc.
3600 E Burnett St.
Long Beach,  CA  90815
Applicant Contact Sean Song
Correspondent
Esthetic Medical, Inc.
3600 E Burnett St.
Long Beach,  CA  90815
Correspondent Contact Sean Song
Regulation Number878.4430
Classification Product Code
QAI  
Date Received09/19/2025
Decision Date 02/19/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT06032286
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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