The following data is part of a premarket notification filed by Syneron Beauty with the FDA for Tanda Pearl, Ultrawyte, Pearl.
| Device ID | K122725 |
| 510k Number | K122725 |
| Device Name: | TANDA PEARL, ULTRAWYTE, PEARL |
| Classification | Heat Source For Bleaching Teeth |
| Applicant | SYNERON BEAUTY 1835 MARKET ST., 29TH FLOOR Philadelphia, PA 19103 |
| Contact | Janice M Hogan |
| Correspondent | Janice M Hogan SYNERON BEAUTY 1835 MARKET ST., 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | EEG |
| CFR Regulation Number | 872.6475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-05 |
| Decision Date | 2012-11-27 |
| Summary: | summary |