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 |