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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 K121598
Device Name ME HAIR2GO
Applicant
SYNERON MEDICAL LTD.
1835 MARKET ST, 29TH FLOOR
PHILADELPHIA,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
SYNERON MEDICAL LTD.
1835 MARKET ST, 29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number878.4810
Classification Product Code
ONF  
Date Received05/31/2012
Decision Date 10/12/2012
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
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