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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name heat source for bleaching teeth
510(k) Number K122725
Device Name TANDA PEARL, ULTRAWYTE, PEARL
Applicant
SYNERON BEAUTY
1835 MARKET ST., 29TH FLOOR
PHILADELPHIA,  PA  19103
Applicant Contact JANICE M HOGAN
Correspondent
SYNERON BEAUTY
1835 MARKET ST., 29TH FLOOR
PHILADELPHIA,  PA  19103
Correspondent Contact JANICE M HOGAN
Regulation Number872.6475
Classification Product Code
EEG  
Date Received09/05/2012
Decision Date 11/27/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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