LYKOS Assisted Reproduction Laser With Dynamic Targeting System (DTS)
Hamilton Thorne, Inc.
HAMILTON THORNE, Inc.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1221433 | 1221433 | HAMILTON THORNE, Inc. | 1 | Y | 2026-01-01 | 100 CUMMINGS CENTER-SUITE 465E Beverly MA US 01915 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 70044 | 1218257039 | K920719 | IVOS ANALYZER | GKL | 1992-06-29 |
| 70044 | 1244187119 | K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | MRX | 2021-07-02 |
| 70044 | 2012401044 | K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | POV | 2020-10-28 |
| 70044 | 1345097207 | K192644 | GM501 SpermAir and GM501 SpermActive | MQL | 2020-04-23 |
| 70044 | 1710580520 | K192503 | GM501 Wash with Phenol Red and Gentamicin | MQL | 2020-11-19 |
| 70044 | 1986872790 | K191552 | GM501 Mineral Oil | MQL | 2019-09-18 |
| 70044 | 1489583447 | K190383 | GM501 Wash | MQL | 2019-09-05 |
| 70044 | 1698890908 | K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | POV | 2018-11-16 |
| 70044 | 1318598208 | K180304 | Geri Embryo Incubator and Geri Dish | MQG | 2018-04-20 |
| 70044 | 1595700857 | K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish | MQG | 2018-06-07 |
| 70044 | 1228158804 | K170498 | Gems Oocyte Retrieval Buffer ORB-20, ORB-50 | MQL | 2017-09-28 |
| 70044 | 1949206362 | K162409 | Gems Vitrification Set, Gems Warming Set | MQL | 2017-05-24 |
| 70044 | 1482354960 | K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase | MQL | 2017-05-12 |
| 70044 | 1733098351 | K120055 | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS | MRX | 2012-04-24 |
| 70044 | 1741533406 | K070135 | VITRIFREEZE MEDIUM; VITRITHAW MEDIUM | MQL | 2007-08-16 |
| 70044 | 1783523524 | K063636 | ZILOS-TK | MRX | 2007-04-24 |
| 70044 | 1547077694 | K053494 | OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE | MQL | 2006-03-23 |
| 70044 | 1347868425 | K013536 | EMTRAC; DELPHIN; SEMTRAC 2000 SET | MQF | 2001-11-30 |
| 70044 | 1524733723 | K013501 | IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B | MQF | 2001-11-30 |
| 70044 | 1166658009 | ||||
| 70044 | 1953251381 | ||||
| 70044 | 1025298460 | ||||
| 70044 | 1032886297 | ||||
| 70044 | 1044199914 | ||||
| 70044 | 1168470372 | ||||
| 70044 | 1432807576 | ||||
| 70044 | 1481156719 | ||||
| 70044 | 1571169826 |
Product Codes Associated With Registrations#
PMN#
GM501 Wash
Hamilton Thorne, Inc.
HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS
HAMILTON THORNE, INC.
GUDID#
Intelligent ICSI Micropipette - Micropipette, ICSI, Feature Type 3, 90µm, 1.00mm
2024-12-11
LYKOS DTS - This system is intended for in vitro fertilization (IVF) laboratory use to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate during assisted reproduction hatching procedures, and to biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening.
2023-06-07
ZILOS-tk™ - This system is intended for in vitro fertilization (IVF) laboratory use to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate during assisted reproduction hatching procedures, and to biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening.
2019-11-30
LYKOS™ - This system is intended for in vitro fertilization (IVF) laboratory use to ablate a small, tangential hole or thin the zona pellucida of select IVF embryos to facilitate during assisted reproduction hatching procedures, and to biopsy trophectoderm cells from blastocyst stage embryos for purposes of preimplantation genetic diagnosis or screening.
2019-11-30
IVOS - A self-contained computerized optical analyzer used for evaluation of sperm samples. It will provide concentration, velocity, morph and motion parameters, which aid the clinician in evaluation of semen quality.
2019-11-30
CEROS - A modular computerized optical analyzer used for evaluation of sperm samples. It will provide concentration, velocity, morph and motion parameters, which aid the clinician in evaluation of semen quality.
2019-11-30
accu-beads® - accu-beads® are intended for use as a quality control material to assist in verifying the accuracy and precision of manual and automated sperm concentration measurements.
2022-03-30
GM501 Gradient 45% - GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.
2021-04-30
GM501 Gradient 45% - GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.
2021-04-30
GM501 Gradient 45% - GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.
2021-04-30
GM501 Gradient 100% - GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with a density of approximately 1.12g/ml. GM501 Gradient 100% can be used in combination with IUI, IVF, and ICSI procedures.
2021-04-30
GM501 Gradient 100% - GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with a density of approximately 1.12g/ml. GM501 Gradient 100% can be used in combination with IUI, IVF, and ICSI procedures.
2021-04-30
GM501 Gradient 100% - GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with a density of approximately 1.12g/ml. GM501 Gradient 100% can be used in combination with IUI, IVF, and ICSI procedures.
2021-04-30
GM501 Gradient 45% - GM501 Gradient 45% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.
2021-04-30
GM501 Gradient 90% - GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.
2021-04-30
GM501 Gradient 90% - GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.
2021-04-30
GM501 Gradient 90% - GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.
2021-04-30
GM501 Gradient 90% - GM501 Gradient 90% is a ready-to-use gradient system for semen preparation and can be used in combination with IUI, IVF, and ICSI procedures.
2021-04-30
GM501 Gradient 100% - GM501 Gradient 100% is a stock solution for semen preparation. It is a ready-to-use isotonic gradient for semen preparation with a density of approximately 1.12g/ml. GM501 Gradient 100% can be used in combination with IUI, IVF, and ICSI procedures.
2021-04-30
Intelligent ICSI Micropipette - Micropipette, ICSI, Feature Type 4, 7.0µm, 2.00mm
2020-02-19
Intelligent ICSI Micropipette - Micropipette, ICSI, Feature Type 3, 4.5µm
2019-11-20
Intelligent ICSI Micropipette - Micropipette, ICSI, Feature Type 2, 4.5µm, 0.75mm
2019-11-20
Intelligent ICSI Micropipette - Micropipette, ICSI, Feature Type 5, 4.5µm
2019-11-20
Intelligent ICSI Micropipette - Micropipette, ICSI, Feature Type 1, 5.0µm
2019-11-20
Intelligent ICSI Micropipette - Micropipette, ICSI, Feature Type 3, 5.0µm
2019-11-20
Intelligent ICSI Micropipette - Micropipette, ICSI, Feature Type 2, 5.0µm, 0.75mm
2019-11-20
Intelligent ICSI Micropipette - Micropipette, ICSI, Feature Type 1, 5.5µm
2019-11-20
Intelligent ICSI Micropipette - Micropipette, ICSI, Feature Type 3, 5.5µm
2019-11-20
Intelligent ICSI Micropipette - Micropipette, ICSI, Feature Type 2, 4.5µm, 0.55mm
2019-11-20
Intelligent ICSI Micropipette - Micropipette, ICSI, Feature Type 4, 5.0µm, 2.00mm
2019-11-20
Expert Holding Micropipette - Micropipette, Holding, 70µm, Slim (10-15µm), 0.65mm
2019-11-20
Expert Holding Micropipette - Micropipette, Holding, 90µm, Normal (15-20µm), 0.65mm
2019-11-20
Expert Holding Micropipette - Micropipette, Holding, 100µm, Normal (15-20µm), 0.65mm
2019-11-20
Expert Holding Micropipette - Micropipette, Holding, 120µm, Normal (15-20µm), 0.65mm
2019-11-20
Expert Holding Micropipette - Micropipette, Holding, 120µm, Broad (25-30µm), 0.65mm
2019-11-20
Expert Holding Micropipette - Micropipette, Holding, 130µm, Normal (15-20µm), 0.65mm
2019-11-20
Expert Holding Micropipette - Micropipette, Holding, 130µm, Broad (25-30µm), 0.65mm
2019-11-20
Expert Holding Micropipette - Micropipette, Holding, 150µm, Normal (15-20µm), 0.65mm
2019-11-20
Expert Holding Micropipette - Micropipette, Holding, 150µm, Broad (25-30µm), 0.65mm
2019-11-20
Expert Holding Micropipette - Micropipette, Holding, 180µm, Broad (25-30µm), 0.65mm
2019-11-20