The following data is part of a premarket notification filed by Asclepion Laser Technologies Gmbh with the FDA for The Mediostar Next Family.
| Device ID | K143519 |
| 510k Number | K143519 |
| Device Name: | The MeDioStar NeXT Family |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ASCLEPION LASER TECHNOLOGIES GMBH BRUESSELER STR. 10 Jena, DE 07747 |
| Contact | Antje Katzer |
| Correspondent | Antje Katzer ASCLEPION LASER TECHNOLOGIES GMBH BRUESSELER 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 | 2014-12-12 |
| Decision Date | 2015-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04058784000101 | K143519 | 000 |
| 04058784000095 | K143519 | 000 |
| 04058784000071 | K143519 | 000 |