Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1221433

FEI Number

1221433

Entity Name

HAMILTON THORNE, Inc.

City/State/Country

Beverly, MA, US

Establishment Address

100 CUMMINGS CENTER-SUITE 465E, Beverly, MA 01915, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Hamilton Thorne, Inc. (Owner Number: 1221433)

Owner / Operator Contact Address

100 Cummings Center, Suite 465E, Beverly, MA 01915, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K920719

PMA Number

N/A

All Registered Proprietary Names

LensHooke X1 PRO SE Semen Quality Analyzer 4-Chamber Analysis Slide GM501 VitriStore Freeze Kit GM501 VitriStore Thaw Kit LYKOS Assisted Reproduction Laser With Dynamic Targeting System (DTS) GM501 Gradient 100% GM501 Gradient 90% GM501 Gradient 45% GM501 SpermStore LensHooke Sperm DNA Fragmentation Test Kit Gems Sperm Buffer Gems Sperm Medium Gems Sperm Wash Gradient Set (45% And 90%) GM501 SpermMobil GM508 CultActive Sterica 210/270 Javica 120/150 Unica Classica 180 Classica 150 Javica 210 Sterica 120 Javica 180 Javica 240 Classica 120 Sterica 180 Econica 120 Sterica 90 Sterica 150 Econica 60 Classica 90 Gynemed Assisted Reproduction Microtools Gynemed Holding Pipette Gynemed ICSI Gynemed Biopsy Pipette Gynemed Gynemed Microtools GM501 Wash with Phenolred and Gentamicin (PRG) #2000 Semtrac Set 5 #4219 Emtrac Set #4000 Tulip #4219 Emtrac Delphin #4219 Emtrac A Geri Water Bottle Geri Dish Geri Embryo Incubator Gems Fertilisation Medium Gems Blastocyst Medium Gems VitBase Gems Cleavage Medium Gems Geri Medium LensHooke C-KUP Liquefaction Test Cup LensHooke Semen Test Cassette LensHooke X1 Pro Semen Quality Analyzer LensHooke Liquefaction Test Cup LensHooke X1 Semen Quality Analyzer LensHooke Semen Quality Analyzer GM501 Mineral Oil Geri Connect Server (including software) Geri Software Connect and Assess Gems Oocyte Retrieval Buffer LYKOS ZILOS-tk ZILOS-tk #4225 Smooze Long #4220 IUI Memo #4225 Smooze Medium #4220 IUI #4220 Plus #4225 Smooze HELOS IVOS TELOS IVOS II-v14 CEROS

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2021-08-24
PUD	Labware, Assisted Reproduction, Exempt	Obstetrics/Gynecology	Class 2	884.6160	2021-10-05
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2024-04-26
MRX	System, Assisted Reproduction Laser	Obstetrics/Gynecology	Class 2	884.6200	2021-10-05
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-11-19
IAF	Wright'S Stain	Hematology	Class 1	864.1850	2021-07-30
QKI	Media, Reproductive, Exempt	Obstetrics/Gynecology	Class 2	884.6180	2020-09-10
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2022-03-10
PUC	Microtools, Assisted Reproduction (Pipettes), Exempt	Obstetrics/Gynecology	Class 2	884.6130	2017-08-24
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2024-04-08
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2024-04-26
MQK	Labware, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6160	2020-12-03
MTX	Microscope And Microscope Accessories, Reproduction, Assisted	Obstetrics/Gynecology	Class 1	884.6190	2020-12-03
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2020-12-03
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-12-03
GKZ	Counter, Differential Cell	Hematology	Class 2	864.5220	2019-10-04
POV	Semen Analysis Device	Hematology	Class 2	864.5220	2019-10-04
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-03-11
MQG	Accessory, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6120	2020-12-03
MQL	Media, Reproductive	Obstetrics/Gynecology	Class 2	884.6180	2020-12-03
MRX	System, Assisted Reproduction Laser	Obstetrics/Gynecology	Class 2	884.6200	2012-07-10
MRX	System, Assisted Reproduction Laser	Obstetrics/Gynecology	Class 2	884.6200	2007-10-10
MQF	Catheter, Assisted Reproduction	Obstetrics/Gynecology	Class 2	884.6110	2024-04-26
GKL	Counter, Cell, Automated (Particle Counter)	Hematology	Class 2	864.5200	2007-10-10

Official Correspondent

Nicole Thibodeau

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hamilton Thorne, Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K011481	Conception Technologies	10% PVP; 10% PVP IN EBSS SOLUTION	2001-07-02
K112396	Kitazato Medical Co., Ltd.	IUI CATHETERS	2012-11-02
K910283	Danam Electronics	DANAM DATACELL-18	1991-04-12
K102064	Becton, Dickinson & CO	BD FACS SAMPLE PREP ASSISTANT III (SPA III)	2011-03-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
Z-0029-2020	CooperSurgical, Inc.	2	Embryology Heated Plate within the RI Witness, Model Numbers 6-70-807, 6-70-807-A, & 6-70-807-B - Product Usage: RI Witness uses Radio Frequency Identification (RFID) to detect and monitor all activity in the IVF laboratory. The system helps mitigate the risk of human error every time samples are moved from one dish or tube to another, and safeguards every step of the IVF cycle. While the heated plates comprise a heated composite surface with window for a light source. The heated plates comprise a heated composite surface with window for a light source and either sit on top of existing bench-tops or can be integrated to be flush fitted within workstations. Intended use: Provide a favorable temperature environment for the embryo during the IVF procedure.
Z-0002-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter
Z-0003-05	ABX Diagnostics Inc	2	Automated Differential Cell Counter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221433. Last updated year: 2026. Please use registration number 1221433 when referencing this establishment in official correspondence.