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 Number | 872.6475
|
Classification Product Code |
|
Date Received | 09/05/2012 |
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
|
|
|