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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 K231073
Device Name SkinStylus SteriLock® MicroSystem, Model Number MP1209SL
Applicant
Esthetic Medical, Inc.
7950 E. Acoma Dr., Suite 208
Scottsdale,  AZ  85260
Applicant Contact Kristin Groop
Correspondent
Contract In-House Counsel and Consultants,
Llc (D/B/A Fda Atty)
1717 Pennsylvania Ave. NW Suite 1025
Washington,  DC  20006
Correspondent Contact Marc C Sanchez
Regulation Number878.4430
Classification Product Code
QAI  
Date Received04/14/2023
Decision Date 07/28/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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