DA VINCI FEMTOSECOND SURGICAL LASER
Powered Laser Surgical Instrument
SIE LTD SURGICAL INSTRUMENT ENGINEERING
The following data is part of a premarket notification filed by Sie Ltd Surgical Instrument Engineering with the FDA for Da Vinci Femtosecond Surgical Laser.
Pre-market Notification Details
| Device ID | K053511 |
| 510k Number | K053511 |
| Device Name: | DA VINCI FEMTOSECOND SURGICAL LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SIE LTD SURGICAL INSTRUMENT ENGINEERING 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls SIE LTD SURGICAL INSTRUMENT ENGINEERING 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-16 |
| Decision Date | 2006-03-10 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640167750894 | K053511 | 000 |
| 07640167750702 | K053511 | 000 |
| 07640167750696 | K053511 | 000 |
| 07640167750689 | K053511 | 000 |
| 07640167750672 | K053511 | 000 |
| 07640167750665 | K053511 | 000 |
| 07640167750658 | K053511 | 000 |
| 07640167750641 | K053511 | 000 |
| 07640167750634 | K053511 | 000 |
| 07640167750719 | K053511 | 000 |
| 07640167750726 | K053511 | 000 |
| 07640167750733 | K053511 | 000 |
| 07640167750887 | K053511 | 000 |
| 07640167750870 | K053511 | 000 |
| 07640167750863 | K053511 | 000 |
| 07640167750788 | K053511 | 000 |
| 07640167750771 | K053511 | 000 |
| 07640167750764 | K053511 | 000 |
| 07640167750757 | K053511 | 000 |
| 07640167750740 | K053511 | 000 |
| 07640167750054 | K053511 | 000 |
Trademark Results [DA VINCI FEMTOSECOND SURGICAL LASER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 DA VINCI FEMTOSECOND SURGICAL LASER 78698021 not registered Dead/Abandoned |
SIE AG 2005-08-23 |
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