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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name massager, vacuum, light induced heating
510(k) Number K182453
Device Name ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
Applicant
I-TECH INDUSTRIES SRL
Via Cicogna 34/b
san lazzaro di savena,  IT 40068
Applicant Contact paolo abbreviato
Correspondent
Mansour Consulting LLC
845 Aronson Lake Court
roswell,  GA  30075
Correspondent Contact jay mansour
Regulation Number878.4810
Classification Product Code
NUV  
Date Received09/07/2018
Decision Date 01/11/2019
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
summary summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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