The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Pitanga.
| Device ID | K031489 |
| 510k Number | K031489 |
| Device Name: | PITANGA |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SYNERON MEDICAL LTD. POB 550 Yokneam Elite, IL 20692 |
| Contact | Amir Waldman |
| Correspondent | Amir Waldman SYNERON MEDICAL LTD. POB 550 Yokneam Elite, IL 20692 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-12 |
| Decision Date | 2003-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109951959 | K031489 | 000 |
| 07290109951942 | K031489 | 000 |
| 07290109951713 | K031489 | 000 |
| 07290109951515 | K031489 | 000 |
| 07290109951386 | K031489 | 000 |
| 07290109950228 | K031489 | 000 |
| 07290109950150 | K031489 | 000 |
| 07290109950143 | K031489 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PITANGA 78766112 3168210 Dead/Cancelled |
Syneron Canada Corporation 2005-12-03 |