FDA.reportPublic FDA data

ZILOS-tk™

Primary DI
00858604006276
Brand
ZILOS-tk™
Company
HAMILTON THORNE, INC.
Model
ZILOS-tk
Device description
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.
Published
2019-11-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
MRXSystem, Assisted Reproduction Laser

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MRXSystem, Assisted Reproduction LaserObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063636000
K120055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063636000ZILOS-TKHamilton Thorne Biosciences2007-04-24MRX
K120055000HANILTON THORNE INFRARED LASER OPTICAL SYSTEM-ZILOS-TK HAMILTON THORNE INFRARED LASER OPTICAL SYSTEM-LYKOSHamilton Thorne, Inc.2012-04-24MRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858604006276PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858604006276008586040062768586040062760858604006276

GMDN Terms#

Term, Definition table
TermDefinition
Assisted reproduction laser systemA portable, mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a low-intensity laser beam to ablate the zona pellucida of an embryo during in vitro fertilization (IVF), typically as part of laser-assisted embryo hatching or embryo biopsy. It is intended to be used in conjunction with a compatible inverted-stage light microscope and typically includes a combined laser/microscope objective, a control unit, a camera, and additional supportive devices (e.g., software, foot-switch).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
152161337
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858604006061Intelligent ICSI MicropipetteIC.3.90.xx.B2024-12-11
00858604006054LYKOS DTSLYKOS DTS2023-06-07
00858604006290LYKOS™LYKOS2019-11-30
00858604006108IVOSIVOS2019-11-30
00858604006719CEROSCEROS2019-11-30
00858604006016accu-beads®accu-beads®2022-03-30
00858604006115GM501 Gradient 45%4GM501GR-45-102021-04-30
00858604006122GM501 Gradient 45%4GM501GR-45-502021-04-30
00858604006139GM501 Gradient 45%4GM501GR-45-1002021-04-30
00858604006221GM501 Gradient 100%4GM501G-100-1002021-04-30
00858604006238GM501 Gradient 100%4GM501G-100-2502021-04-30
00858604006245GM501 Gradient 100%4GM501G-100-5002021-04-30
00858604006146GM501 Gradient 45%4GM501GR-45-2502021-04-30
00858604006177GM501 Gradient 90%4GM501GR-90-102021-04-30
00858604006184GM501 Gradient 90%4GM501GR-90-502021-04-30
00858604006191GM501 Gradient 90%4GM501GR-90-1002021-04-30
00858604006207GM501 Gradient 90%4GM501GR-90-2502021-04-30
00858604006214GM501 Gradient 100%4GM501G-100-502021-04-30
00858604006351Intelligent ICSI MicropipetteIC.4.70.xx.C2020-02-19
00858604006320Intelligent ICSI MicropipetteIC.3.45.xx.A2019-11-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858604006054LYKOS DTSHAMILTON THORNE, INC.MRX2023-06-07
04260604170011Octax LaserShot MOctax Microscience GmbHMRX2020-05-11
04260604170028Octax NaviLaseOctax Microscience GmbHMRX2020-05-11
00858604006290LYKOS™HAMILTON THORNE, INC.MRX2019-11-30
05060488042393Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042409Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042669Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042676Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042683Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042690Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042706Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042713Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042720Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042737Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042744Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042751Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042768Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488042812Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043277Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043338Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043406Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043628Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043635Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043772Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488043789Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488044816Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488044823Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488044830Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488044847Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
05060488044915Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23