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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 K240132
Device Name EmoLED (v. 2-USA)
Applicant
Emoled, Srl
Via Di Rimaggio 141/Interno 25
Sesto Fiorentino,  IT 50019
Applicant Contact Lorenzo Targetti
Correspondent
RESound Clinical Consulting, LLC
19 Chipping Norton Ln.
Bedford,  NH  03110
Correspondent Contact Robert Swain
Regulation Number878.4810
Classification Product Code
GEX  
Date Received01/17/2024
Decision Date 03/12/2024
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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