FDA.reportPublic FDA data

Saturn 5 Laser System

Primary DI
05060488043628
Brand
Saturn 5 Laser System
Company
RESEARCH INSTRUMENTS LIMITED
Model
Saturn 5 Active Nikon Diaphot200-300
Catalog number
6-47-500-23
Device description
Assisted Reproduction Laser
Published
2018-02-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K141434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141434000SATURN 5 LASERResearch Instruments , Ltd.2015-02-18MRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05060488043628PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488043628050604880436285060488043628

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

Contacts#

Phone, Email table
PhoneEmail
+4546790202origio@origio.com

Regulatory Flags#

DUNS number
536139413
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05060170181454EZ-Tip125 micron tip id7-72-2125/52017-12-22
05060170181461EZ-Tip135 micron tip id7-72-2135/52017-12-22
05060170181478EZ-Tip145 micron tip id7-72-2145/52017-12-22
05060170181485EZ-Tip155 micron tip id7-72-2155/52017-12-22
05060170181492EZ-Tip170 micron tip id7-72-2170/52017-12-22
05060170181508EZ-Tip200 micron tip id7-72-2200/52017-12-22
05060170181515EZ-Tip290 micron tip id7-72-2290/52017-12-22
05060170181522EZ-Tip600 micron tip id7-72-2600/52017-12-22
05060170181539EZ-Tip125 micron tip id7-72-4125/202017-12-22
05060170181546EZ-Tip135 micron tip id7-72-4135/202017-12-22
05060170181553EZ-Tip145 micron tip id7-72-4145/202017-12-22
05060170181560EZ-Tip155 micron tip id7-72-4155/202017-12-22
05060170181577EZ-Tip170 micron tip id7-72-4170/202017-12-22
05060170181591EZ-Tip200 micron tip id7-72-4200/202017-12-22
05060170181607EZ-Tip290 micron tip id7-72-4290/202017-12-22
05060170181614EZ-Tip600 micron tip id7-72-4600/202017-12-22
05060170181690EZ-GripEZ-Grip7-72-28002017-12-22
05060170183328EZ-Tip75 micron tip id7-72-2075/52017-12-22
05060170183380EZ-GripEZ-Grip with Comfort Rest7-72-28022017-12-22
05060170183441EZ-Tip75 micron tip id7-72-4075/202017-12-22

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
00858604006276ZILOS-tk™HAMILTON THORNE, INC.MRX2019-11-30
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
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