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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrosurgical, Cutting & Coagulation & Accessories
510(k) Number K201520
Device Name The Alma Opus System, Colibri Applicator and Tips
Applicant
Alma Lasers, Inc.
485 Half Day Rd.
Suite 100
Buffalo Grove,  IL  60089
Applicant Contact Jessica Rivera-Montejo
Correspondent
Kathy Maynor Consulting
26 Rebecca Ct.
Homosassa,  FL  34446
Correspondent Contact Kathy Maynor
Regulation Number878.4400
Classification Product Code
GEI  
Date Received06/08/2020
Decision Date 10/27/2021
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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