The following data is part of a premarket notification filed by Syneron Candela Corporation with the FDA for Profound System.
| Device ID | K161043 |
| 510k Number | K161043 |
| Device Name: | Profound System |
| Classification | Massager, Vacuum, Radio Frequency Induced Heat |
| Applicant | SYNERON CANDELA CORPORATION 530 BOSTON POST ROAD Wayland, MA 01778 |
| Contact | Ruthie Amir |
| Correspondent | Janice M. Hogan HOGAN LOVELLS US LLP 1835 MARKET STREET 29TH FLOOR Philadelphia, PA 19103 |
| Product Code | PBX |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-13 |
| Decision Date | 2016-09-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109952642 | K161043 | 000 |
| 07290109952635 | K161043 | 000 |
| 00817495024240 | K161043 | 000 |
| 00817495023892 | K161043 | 000 |
| 00817495023885 | K161043 | 000 |
| 00817495023847 | K161043 | 000 |
| 00817495023700 | K161043 | 000 |
| 00817495024387 | K161043 | 000 |
| 00817495024370 | K161043 | 000 |