FDA.reportPublic FDA data

RI Saturn

Primary DI
05060488047480
Brand
RI Saturn
Company
RESEARCH INSTRUMENTS LIMITED
Model
6-47-500-29
Catalog number
6-47-500-29
Device description
RI Saturn 5 Active Zeiss Axiovert 5 40x obj
Published
2026-07-14
Public version status
New
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
05060488047480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488047480050604880474805060488047480

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).

Regulatory Flags#

DUNS number
536139413
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
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