The following data is part of a premarket notification filed by Hamilton Thorne, Inc. with the FDA for Lykos Assisted Reproduction Laser With Dynamic Targeting System (dts).
| Device ID | K202241 |
| 510k Number | K202241 |
| Device Name: | LYKOS Assisted Reproduction Laser With Dynamic Targeting System (DTS) |
| Classification | System, Assisted Reproduction Laser |
| Applicant | Hamilton Thorne, Inc. 100 Cummings Center, Suite 465E Beverly, MA 01915 |
| Contact | Donald Fournier |
| Correspondent | Donald Fournier Hamilton Thorne, Inc. 100 Cummings Center, Suite 465E Beverly, MA 01915 |
| Product Code | MRX |
| CFR Regulation Number | 884.6200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-10 |
| Decision Date | 2021-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858604006054 | K202241 | 000 |