The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Aurora Ds.
Device ID | K021149 |
510k Number | K021149 |
Device Name: | AURORA DS |
Classification | Powered Laser Surgical Instrument |
Applicant | SYNERON MEDICAL LTD. POB 550 Yokneam Elite, IL 20692 |
Contact | Amir Waldmann |
Correspondent | Amir Waldmann 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 | 2002-04-10 |
Decision Date | 2002-07-09 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
AURORA DS 78079671 not registered Dead/Abandoned |
SYNERON INC. 2001-08-16 |