Data / Medical devices / United States / HAMILTON THORNE, Inc.
HAMILTON THORNE, Inc.: FDA-registered device maker in Beverly, MA, United States, 19 510(k) clearances
HAMILTON THORNE, Inc. is registered with the FDA (registration 1221433) in Beverly, MA, United States. It lists 18 device types. The FDA files 19 510(k) clearances under its listings, the newest dated July 2, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1221433
- Address
- 100 Cummings Center-Suite 465e, Beverly, MA, United States, 01915
- Owner or operator
- Hamilton Thorne, Inc. (1221433)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- October 10, 2007
- Registered through
- 2026
- Brand names listed
- #2000 Semtrac Set 5, #4000 Tulip, #4219 Emtrac A, #4219 Emtrac Delphin, #4219 Emtrac Set, #4220 IUI, #4220 IUI Memo, #4220 Plus and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 2, 2021 | K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) | MRX | Substantially Equivalent | Hamilton Thorne, Inc. | accessdata.fda.gov |
| November 19, 2020 | K192503 | GM501 Wash with Phenol Red and Gentamicin | MQL | Substantially Equivalent | Hamilton Thorne Incorporated | accessdata.fda.gov |
| October 28, 2020 | K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO SE Semen Quality Analyzer | POV | Substantially Equivalent | Bonraybio Co., Ltd. | accessdata.fda.gov |
| April 23, 2020 | K192644 | GM501 SpermAir and GM501 SpermActive | MQL | Substantially Equivalent | Hamilton Thorne Incorporated | accessdata.fda.gov |
| September 18, 2019 | K191552 | GM501 Mineral Oil | MQL | Substantially Equivalent | Hamilton Thorne, Inc. | accessdata.fda.gov |
| September 5, 2019 | K190383 | GM501 Wash | MQL | Substantially Equivalent | Hamilton Thorne, Inc. | accessdata.fda.gov |
| November 16, 2018 | K180343 | LensHooke X1 Pro Semen Quality Analyzer, LensHooke X1 Semen Quality Analyzer | POV | Substantially Equivalent | Bonraybio Co., Ltd. | accessdata.fda.gov |
| June 7, 2018 | K180188 | Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish | MQG | Substantially Equivalent | Genea Biomedx Pty, Ltd. | accessdata.fda.gov |
| April 20, 2018 | K180304 | Geri Embryo Incubator and Geri Dish | MQG | Substantially Equivalent | Genea Biomedx Pty, Ltd. | accessdata.fda.gov |
| September 28, 2017 | K170498 | Gems Oocyte Retrieval Buffer ORB-20, ORB-50 | MQL | Substantially Equivalent | Genea Biomedx Pty, Ltd. | accessdata.fda.gov |
| May 24, 2017 | K162409 | Gems Vitrification Set, Gems Warming Set | MQL | Substantially Equivalent | Genea Biomedx Pty, Ltd. | accessdata.fda.gov |
| May 12, 2017 | K161261 | Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase | MQL | Substantially Equivalent | Genea Biomedx Pty, Ltd. | accessdata.fda.gov |
| April 24, 2012 | K120055 | HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOS | MRX | Substantially Equivalent | Hamilton Thorne, Inc. | accessdata.fda.gov |
| August 16, 2007 | K070135 | VITRIFREEZE MEDIUM; VITRITHAW MEDIUM | MQL | Substantially Equivalent | Fertipro NV | accessdata.fda.gov |
| April 24, 2007 | K063636 | ZILOS-TK | MRX | Substantially Equivalent | Hamilton Thorne Biosciences | accessdata.fda.gov |
| March 23, 2006 | K053494 | OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE | MQL | Substantially Equivalent | Fertipro NV | accessdata.fda.gov |
| November 30, 2001 | K013536 | EMTRAC; DELPHIN; SEMTRAC 2000 SET | MQF | Substantially Equivalent | Gynetics Medical Products NV | accessdata.fda.gov |
| November 30, 2001 | K013501 | IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B | MQF | Substantially Equivalent | Gynetics Medical Products NV | accessdata.fda.gov |
| June 29, 1992 | K920719 | IVOS ANALYZER | GKL | Substantially Equivalent | Hamilton Thorne Research | accessdata.fda.gov |
Compare with other makers
- All makers of Counter, Cell, Automated (Particle Counter)
- All makers of Accessory, Assisted Reproduction
- All makers of System, Assisted Reproduction Laser
- All makers of Media, Reproductive
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
- All makers of Labware, Assisted Reproduction
Updated July 2, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.