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 |