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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K181298
Device Name Harmony XL Multi-Application Platform
Applicant
Alma Lasers, Inc.
485 Half Day Rd.
Suite 100
Buffalo Grove,  IL  60089
Applicant Contact Rekha Anand
Correspondent
Hogan Lovells US LLP
1735 Market St.
23rd Floor
Philadelphia,  PA  19103
Correspondent Contact Janice M. Hogan
Regulation Number878.4810
Classification Product Code
ONF  
Date Received05/16/2018
Decision Date 06/13/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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