SkyPulse
Powered Laser Surgical Instrument
Fotona D.o.o.
The following data is part of a premarket notification filed by Fotona D.o.o. with the FDA for Skypulse.
Pre-market Notification Details
| Device ID | K193656 |
| 510k Number | K193656 |
| Device Name: | SkyPulse |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Fotona D.o.o. Stegne 7 Ljubljana, SI Si-1000 |
| Contact | Marko Berdajs |
| Correspondent | Marko Berdajs Fotona D.o.o. Stegne 7 Ljubljana, SI Si-1000 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-30 |
| Decision Date | 2020-03-27 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03830054230408 | K193656 | 000 |
| 03830054230392 | K193656 | 000 |
| 03830054230934 | K193656 | 000 |
| 03830054230927 | K193656 | 000 |
Trademark Results [SkyPulse]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SKYPULSE 98460758 not registered Live/Pending |
Salaam RE Harris 2024-03-21 |
 SKYPULSE 79179412 4967018 Live/Registered |
FOTONA d.o.o. 2015-10-13 |
 SKYPULSE 78042262 not registered Dead/Abandoned |
SkyPulse Technology, Inc. 2001-01-09 |
 SKYPULSE 76175746 2847904 Dead/Cancelled |
Skylite Corporation Kabushiki Kaisha 2000-12-05 |
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