The following data is part of a premarket notification filed by Asclepion Laser Technologies Gmbh with the FDA for Mediostar.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04058784000279 | K192483 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MEDIOSTAR 76200554 2655739 Live/Registered |
ASCLEPION LASER TECHNOLOGIES GMBH 2001-01-26 |