The following data is part of a premarket notification filed by Hamilton Thorne Biosciences with the FDA for Zilos-tk, Version 3, Zilos-tk, Version 4.
| Device ID | K050768 |
| 510k Number | K050768 |
| Device Name: | ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 |
| Classification | System, Assisted Reproduction Laser |
| Applicant | HAMILTON THORNE BIOSCIENCES 181 ELLIOTT ST. 100 CUMMINGS CENTER-SUITE 465E Beverly, MA 01915 -6101 |
| Contact | Diarmaid H Douglas-hamilton |
| Correspondent | Diarmaid H Douglas-hamilton HAMILTON THORNE BIOSCIENCES 181 ELLIOTT ST. 100 CUMMINGS CENTER-SUITE 465E Beverly, MA 01915 -6101 |
| Product Code | MRX |
| CFR Regulation Number | 884.6200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-25 |
| Decision Date | 2005-04-28 |