The following data is part of a premarket notification filed by Asclepion Laser Technologies Gmbh with the FDA for Quadrostar 980.
| Device ID | K060459 |
| 510k Number | K060459 |
| Device Name: | QUADROSTAR 980 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | ASCLEPION LASER TECHNOLOGIES GMBH GOESCHWITZERSTRASSE 51-52 Jena, DE 07745 |
| Contact | Reinhard Thieme |
| Correspondent | Reinhard Thieme ASCLEPION LASER TECHNOLOGIES GMBH GOESCHWITZERSTRASSE 51-52 Jena, DE 07745 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-22 |
| Decision Date | 2006-03-20 |
| Summary: | summary |