AURORA DS
Powered Laser Surgical Instrument
SYNERON MEDICAL LTD.
The following data is part of a premarket notification filed by Syneron Medical Ltd. with the FDA for Aurora Ds.
Pre-market Notification Details
| Device ID | K041969 |
| 510k Number | K041969 |
| Device Name: | AURORA DS |
| 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 | 2004-07-22 |
| Decision Date | 2004-10-19 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290109951232 | K041969 | 000 |
| 07290109950020 | K041969 | 000 |
Trademark Results [AURORA DS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 AURORA DS 78079671 not registered Dead/Abandoned |
SYNERON INC. 2001-08-16 |
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