The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Aurora Ds.
Device ID | K031988 |
510k Number | K031988 |
Device Name: | AURORA DS |
Classification | Powered Laser Surgical Instrument |
Applicant | SYNERON MEDICAL LTD. APPOLO BLD., INDUSTRIAL ZONE Yoqneam Illit, IL 20692 |
Contact | Amir Waldman |
Correspondent | Amir Waldman SYNERON MEDICAL LTD. APPOLO BLD., INDUSTRIAL ZONE Yoqneam Illit, IL 20692 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-06-27 |
Decision Date | 2003-08-01 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AURORA DS 78079671 not registered Dead/Abandoned |
SYNERON INC. 2001-08-16 |