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 |
| 2915796 | 2915796 | HAMILTON CO. | 1 | N | 2026-01-01 | 4970 ENERGY WAY Reno NV US 89502 |
| 8030996 | 3001421318 | HAMILTON BONADUZ AG | 1 | N | 2026-01-01 | VIA CRUSCH 8 BONADUZ Graubunden CH 7402 |
| 1000184527 | 1000184527 | HAMILTON BEACH BRANDS, INC | 1 | Y | 2026-01-01 | 4421 Waterfront Drive Glen Allen VA US 23060 |
| 3001421318 | 3001421318 | HAMILTON MEDICAL AG | 1 | N | 2026-01-01 | VIA CRUSCH 8 BONADUZ Graubunden CH 7402 |
| 3011971979 | 3011971979 | HAMILTON CENTRAL EUROPE | 1 | N | 2026-01-01 | Hamilton Street No 2-4 Giarmata Timis RO 307210 |
| 3016363085 | 3016363085 | HAMILTON LIFE SCIENCES | 1 | Y | 2026-01-01 | 4186 Nahunta Ct Peachtree Corners GA US 30092 |
| 3016723884 | 3016723884 | HAMILTON MEDICAL, INC. | 1 | Y | 2026-01-01 | 201 Edison Way Reno NV US 89502 |
| 3029906224 | 3029906224 | Hamilton Medical AG | 1 | N | 2026-01-01 | Parc Industrial Vial 12 Domat/Ems Graubunden CH 7013 |
| 2937708 | 2937708 | HAMILTON MEDICAL, INC. | 1 | Y | 2020-04-25 | 4990 ENERGY WAY RENO NV US 89502 |
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 |
| 321839 | 2010359155 | K201658 | Hamilton-C6 | CBK | 2020-12-11 |
| 234834 | 2010359155 | K201658 | Hamilton-C6 | CBK | 2020-12-11 |
| 321839 | 1525272187 | K201306 | HAMILTON-C3 | CBK | 2021-02-05 |
| 234834 | 1525272187 | K201306 | HAMILTON-C3 | CBK | 2021-02-05 |
| 321839 | 1918331697 | K193228 | Hamilton-G5 | CBK | 2020-05-04 |
| 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 |
| 321839 | 1163710339 | K181216 | HAMILTON-T1, HAMILTON-C1 | CBK | 2019-08-02 |
| 234834 | 1163710339 | K181216 | HAMILTON-T1, HAMILTON-C1 | CBK | 2019-08-02 |
| 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 |
| 234834 | 1681896734 | K180295 | Hamilton-G5 | CBK | 2019-07-30 |
| 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 |
| 321839 | 1834321017 | K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 | BTT | 2017-09-20 |
| 234834 | 1834321017 | K163283 | HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010 | BTT | 2017-09-20 |
| 70044 | 1949206362 | K162409 | Gems Vitrification Set, Gems Warming Set | MQL | 2017-05-24 |
| 234834 | 1569010522 | K161450 | HAMILTON-C3 | CBK | 2017-04-27 |
| 70044 | 1482354960 | K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase | MQL | 2017-05-12 |
| 234834 | 1157693734 | K153046 | HAMILTON-MR1 | CBK | 2016-09-06 |
| 321839 | 1157693734 | K153046 | HAMILTON-MR1 | CBK | 2016-09-06 |
| 234834 | 1725650712 | K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 | BTT | 2016-05-03 |
| 321839 | 1725650712 | K152029 | HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010 | BTT | 2016-05-03 |
| 234834 | 1042189066 | K150893 | IntelliCuff | BSK | 2016-01-29 |
| 321839 | 1042189066 | K150893 | IntelliCuff | BSK | 2016-01-29 |
| 321839 | 1994550667 | K121225 | HAMILTON-C2 | CBK | 2012-11-16 |
| 234834 | 1994550667 | K121225 | HAMILTON-C2 | CBK | 2012-11-16 |
| 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 |
| 321839 | 1563215545 | K041781 | VENTILAIR II MEDICAL AIR COMPRESSOR | BTI | 2005-03-14 |
| 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 |
| 41358 | 1216147711 | BK130006 | |||
| 70044 | 1166658009 | ||||
| 41358 | 1276889903 | ||||
| 41358 | 1287607844 | ||||
| 70044 | 1953251381 | ||||
| 41358 | 2016364808 | ||||
| 70044 | 1025298460 | ||||
| 70044 | 1032886297 | ||||
| 38678 | 1042313414 | ||||
| 70044 | 1044199914 | ||||
| 321839 | 1049364433 | ||||
| 234834 | 1049364433 | ||||
| 264306 | 1051417850 | ||||
| 38678 | 1098519889 | ||||
| 70044 | 1168470372 | ||||
| 234834 | 1262169086 | ||||
| 321839 | 1262169086 | ||||
| 264306 | 1327784228 | ||||
| 70044 | 1432807576 | ||||
| 204245 | 1471586811 | ||||
| 204245 | 1471790404 | ||||
| 70044 | 1481156719 | ||||
| 70044 | 1571169826 | ||||
| 204245 | 1590944884 | ||||
| 38678 | 1643257196 | ||||
| 264306 | 1650515124 | ||||
| 38678 | 1756364113 | ||||
| 264306 | 1802383042 | ||||
| 264306 | 1877643489 |
Product Codes Associated With Registrations#
PMN#
HAMILTON-C3
Hamilton Medical AG
Hamilton-C6
Hamilton Medical AG
GM501 Wash with Phenol Red and Gentamicin
Hamilton Thorne Incorporated
Hamilton-G5
Hamilton Medical AG
GM501 SpermAir And GM501 SpermActive
Hamilton Thorne Incorporated
GM501 Mineral Oil
Hamilton Thorne Inc.
GM501 Wash
Hamilton Thorne, Inc.
HAMILTON-T1, HAMILTON-C1
Hamilton Medical AG
HAMILTON-H900, HAMILTON-BC8010, HAMILTON-BC4010
HAMILTON MEDICAL AG
HAMILTON-C3
HAMILTON MEDICAL AG
HAMILTON-MR1
HAMILTON MEDICAL AG
HAMILTON-H900, HAMILTON-BC8022, HAMILTON-BC4022, HAMILTON-BC8010, HAMILTON-BC4010
HAMILTON MEDICAL AG
IntelliCuff
HAMILTON MEDICAL AG
HAMILTON-T1,HAMILTON-C1
HAMILTON MEDICAL AG
HAMILTON-MR1
HAMILTON MEDICAL AG
HAMILTON-G5
HAMILTON MEDICAL AG
HAMILTON-C3
HAMILTON MEDICAL AG
HAMILTON-C2
HAMILTON MEDICAL AG
HAMILTON-C1
HAMILTON MEDICAL AG
HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS
HAMILTON THORNE, INC.
HAMILTON-T1
HAMILTON MEDICAL AG
HAMILTON-TC1
HAMILTON MEDICAL AG
HAMILTON-G5
HAMILTON MEDICAL AG
HAMILTON-C2
HAMILTON MEDICAL AG
HAMILTON-C2
HAMILTON MEDICAL AG
HAMILTON-C2
HAMILTON MEDICAL AG
MODIFICATION TO HAMILTON-G5
HAMILTON MEDICAL AG
MODIFICATION TO GALILEO GOLD
Hamilton Medical AG
HAMILTON-G5
HAMILTON MEDICAL AG
RAPHAEL COLOR ASV VENTILATOR
HAMILTON MEDICAL AG
ZILOS-TK
HAMILTON THORNE BIOSCIENCES
GALILEO GOLD ASV
HAMILTON MEDICAL AG
RAPHAEL COLOR
HAMILTON MEDICAL AG
ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4
HAMILTON THORNE BIOSCIENCES
VENTILAIR II MEDICAL AIR COMPRESSOR
HAMILTON MEDICAL AG
GALILEO GOLD
HAMILTON MEDICAL, INC.
RAPHAEL
Hamilton Medical AG
ARABELLA NCPAP MASKS
HAMILTON MEDICAL AG
AUTOMARQER
HAMILTON THORNE RESEARCH
Applications#
GUDID#
Intelligent ICSI Micropipette - Micropipette, ICSI, Feature Type 3, 90µm, 1.00mm
2024-12-11
HAMILTON-G5 - 5900
2024-08-21
HAMILTON-T1 - 161005
2024-08-21
HAMILTON-C3 - 160006
2024-08-20
HAMILTON-C2 - 160002
2024-08-20
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
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
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
HAMILTON-BC8022 - HAMILTON-BC8022, breathing circuit set, dual limb, heated, with water chamber
2016-10-04
Breathing circuit set, coaxial - Coaxial breathing circuit set with flow sensor expandable limb connection for use with all HAMILTON ventilators, 240 cm, adult/pediatric, single-use
2022-12-08
Expiratory valve set - Expiratory valve set for HAMILTON-C2/C3/C6, adult/pediatric/neonatale, single-use
2022-12-08
Breathing circuit set, coaxial - Coaxial breathing circuit set with flow sensor, expiratory valve and eExpandable limb connection for use with HAMILTON-C2/C3/C6, 180 cm, adult/pediatric, single-use
2022-12-08
Breathing circuit set, coaxial - Coaxial breathing circuit set with expandable limb connection for use with all HAMILTON ventilators, 240 cm, adult/ pediatric, single-use
2022-12-08
Breathing circuit set, dual limb - Dual limb breathing circuit set with Swivel Y-piece for use with all HAMILTON ventilators, 150 cm, neonatal/pediatric, single-use
2022-12-08
Breathing circuit set, dual limb - Dual limb breathing circuit set with Swivel Y-piece for use with all HAMILTON ventilators, 300 cm, neonatal/pediatric, single-use
2022-12-08
Breathing circuit set, dual limb - Dual limb breathing circuit set with Swivel Y-piece, neonatal flow sensor, neonatal expiratory valve set and pressure line for use with HAMILTON-C1/T1/MR1, 300 cm, neonatal, single-use
2022-12-08
Breathing circuit set, dual limb - Dual limb breathing circuit set with Swivel Y-piece, neonatal flow sensor, neonatal expiratory valve set and pressure line for use with HAMILTON-C1/T1/MR1, 150 cm, neonatal, single-use
2022-12-08
Breathing circuit set, coaxial - Coaxial breathing circuit set with flow sensor, expiratory valve and expandable limb connection, 180 cm, for use with HAMILTON-G5/S1adult/ pediatric, single-use
2022-12-08
Expiratory valve set - Expiratory valve set for HAMILTON-G5/S1/GALILEO, single-use
2022-12-08
Expiratory valve set - Expiratory valve set for HAMILTON-C1/T1/MR1, neonatal, autoclavable
2022-12-08
Pressure line - Pressure line for nCPAP / nCPAP-PC for use with all HAMILTON ventilators, 310 cm, neonatal, single-use
2022-12-08
Pressure line - Pressure line for nCPAP / nCPAP-PC for use with all HAMILTON ventilators, 160 cm, neonatal, single-use
2022-12-08
Breathing circuit set, dual limb - Dual limb breathing circuit set with Swivel Y-piece, neonatal flow sensor and pressure line for use with all HAMILTON ventilators, 300 cm, neonatal, single-use
2022-12-08
Breathing circuit set, dual limb - Dual limb breathing circuit set with Swivel Y-piece, neonatal flow sensor and pressure line for use with all HAMILTON ventilators, 150 cm, neonatal, single-use
2022-12-08
Expiratory valve set - Expiratory valve set for HAMILTON-G5/S1, adult/pediatric/neonatale, autoclavable
2022-12-08
Expiratory valve set - Expiratory valve set for HAMILTON-C1/T1/MR1, neonatal, single-use
2022-12-08
Breathing circuit set, coaxial - Coaxial breathing circuit set with flow sensor, expiratory valve, elbow adapter and expandable limb connection for use with HAMILTON-C1/T1/MR1, 480 cm, adult/ pediatric, single-use
2022-12-08
Breathing circuit set, coaxial - Coaxial breathing circuit set with flow sensor, expiratory valve and elbow adapter for use with HAMILTON-C1/T1/MR1, 300 cm, adult/ pediatric, single-use
2022-12-08
Breathing circuit set, coaxial - Coaxial breathing circuit set with flow sensor, expiratory valve and elbow adapter for use with HAMILTON-C1/T1/MR1, 180 cm, adult/ pediatric, single-use
2022-12-08
Breathing circuit set, coaxial - Coaxial breathing circuit set with flow Sensor, expiratory valve and elbow adapter for use with HAMILTON-C1/T1/MR1, 240 cm, adult/ pediatric, single-use
2022-12-08
Flow sensor - Flow sensor for use with all HAMILTON ventilators, 310 cm, neonatal, single-use
2022-12-08
Flow sensor - Flow sensor for use with all HAMILTON ventilators, 160 cm, neonatal, single-use
2022-12-08
Expiratory valve set - Expiratory valve set for HAMILTON-C1/T1/MR1, adult/pediatric, single-use
2022-12-08
Flow sensor - Flow sensor for use with all HAMILTON ventilators, 188 cm, pediatric/adult, autoclavable
2022-12-08
Expiratory valve set - Expiratory valve set for HAMILTON-C1/T1/MR1, adult/pediatric, autoclavable
2022-12-08
Breathing circuit set, coaxial - Coaxial breathing circuit set with flow sensor and elbow adapter for use with HAMILTON-C1/T1/MR1, 300 cm, adult/ pediatric, single-use
2022-12-08
Breathing circuit set, coaxial - Coaxial breathing circuit set with flow sensor and elbow adapter for use with HAMILTON-C1/T1/MR1, 480 cm, adult/ pediatric, single-use
2022-12-08
Flow sensor - Flow sensor for use with all HAMILTON ventilators, 188 cm, neonatal, single-use
2022-12-08
Expiratory valve set - Expiratory valve set for HAMILTON-C2/C3/C6, adult/pediatric, autoclavable
2022-12-08
Breathing circuit set, coaxial - Coaxial breathing circuit set with flow Sensor and Elbow Adapter for use with HAMILTON-C1/T1/MR1, 180 cm, adult/ pediatric, single-use
2022-12-08