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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
Original Applicant
1835 market st, 29th floor
philadelphia,  PA  19103
Original Contact janice m hogan
Regulation Number878.4810
Classification Product Code
Date Received05/31/2012
Decision Date 10/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No