LYKOS™

GUDID 00858604006290

This system is intended to be used to drill a small tangential bole in or to thin the zona pellucida of the embryo in selected in vitro fertilization (IVF) patients with otherwise poor prognosis for successful pregnancy outcome, such as advanced maternal age, prior failed IVF procedures, cryopreserved embryos, or abnormal zona pellucida morphology, and in lyE patients undergoing PGD to avoid genetic disease or aneuploidy.

HAMILTON THORNE, INC.

Assisted reproduction laser system
Primary Device ID00858604006290
NIH Device Record Key1b5fd387-60f3-4722-951b-02bfd8ed9d38
Commercial Distribution StatusIn Commercial Distribution
Brand NameLYKOS™
Version Model NumberLYKOS
Company DUNS152161337
Company NameHAMILTON THORNE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100858604006290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRXSystem, Assisted Reproduction Laser

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-12-09
Device Publish Date2019-11-30

Devices Manufactured by HAMILTON THORNE, INC.

00858604006054 - LYKOS DTS2023-06-15 This system is intended for in vitro fertilization (IVF) laboratory use to ablate a small, tangential hole or thin the zona pell
00858604006016 - accu-beads®2022-04-07 accu-beads® are intended for use as a quality control material to assist in verifying the accuracy and precision of manual and
00858604006146 - GM501 Gradient 45%2021-05-10 GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
00858604006177 - GM501 Gradient 90%2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
00858604006184 - GM501 Gradient 90%2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
00858604006191 - GM501 Gradient 90%2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
00858604006207 - GM501 Gradient 90%2021-05-10 GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICS
00858604006214 - GM501 Gradient 100%2021-05-10 GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with

Trademark Results [LYKOS]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LYKOS
LYKOS
98300349 not registered Live/Pending
Thermo Scientific Portable Analytical Instruments Inc.
2023-12-05
LYKOS
LYKOS
98125023 not registered Live/Pending
Lykos Global Management, LP
2023-08-09
LYKOS
LYKOS
97077089 not registered Live/Pending
Lykos LLC
2021-10-15
LYKOS
LYKOS
88075301 5726409 Live/Registered
HK LYKOS TECHNOLOGY CO.,LIMITED
2018-08-13
LYKOS
LYKOS
86871137 not registered Dead/Abandoned
Daniel Kooden
2016-01-11
LYKOS
LYKOS
85355462 4093780 Live/Registered
Hamilton Thorne, Inc.
2011-06-24
LYKOS
LYKOS
79384950 not registered Live/Pending
Suzhou Lykos Bicycle Co., Ltd.
2023-10-10
LYKOS
LYKOS
79200299 5273485 Live/Registered
VITEC IMAGING SOLUTIONS S.p.A.
2016-04-12
LYKOS
LYKOS
73494488 1334204 Live/Registered
Lykos Corp.
1984-08-13

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