MeDioStar
Powered Laser Surgical Instrument
ASCLEPION LASER TECHNOLOGIES GMBH
The following data is part of a premarket notification filed by Asclepion Laser Technologies Gmbh with the FDA for Mediostar.
Pre-market Notification Details
| Device ID | K192483 |
| 510k Number | K192483 |
| Device Name: | MeDioStar |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ASCLEPION LASER TECHNOLOGIES GMBH Busseler Str. 10 Jena, DE 07747 |
| Contact | Antje Katzer |
| Correspondent | Dania Di Pietro Paolo ASCLEPION LASER TECHNOLOGIES GMBH Busseler Str. 10 Jena, DE 07747 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-10 |
| Decision Date | 2020-03-13 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04058784000279 | K192483 | 000 |
Trademark Results [MeDioStar]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MEDIOSTAR 76200554 2655739 Live/Registered |
ASCLEPION LASER TECHNOLOGIES GMBH 2001-01-26 |
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