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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K230308
Device Name Alma Harmony
Applicant
Alma Lasers, Inc.
485 Half Day Rd.
#100
Buffalo Grove,  IL  60089
Applicant Contact Jessica Rivera Montejo
Correspondent
Alma Lasers, Inc.
485 Half Day Rd.
#100
Buffalo Grove,  IL  60089
Correspondent Contact Jessica Rivera Montejo
Regulation Number878.4810
Classification Product Code
GEX  
Subsequent Product Codes
ILY   ONF  
Date Received02/03/2023
Decision Date 03/01/2023
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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