FDA.reportPublic FDA data

Saturn 5 Laser System

Primary DI
05060488043277
Brand
Saturn 5 Laser System
Company
RESEARCH INSTRUMENTS LIMITED
Model
Saturn 5 Active Nikon TE2000 With Integra 40x
Catalog number
6-47-500-19
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
05060488043277PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05060488043277050604880432775060488043277

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
05060554120956K-SystemsG210 InviCellK595002025-02-25
05060554120963K-SystemsG210 InviCellK595002025-02-25
00888937014488TITANTITAN WTIVFE IVF 120V SERIAL NUMBERWTIVFE-W51202024-09-20
00888937014587MARSMARS 1800 IVF WS 6FT W/RIGHT ELEC HEATWM1800RE2024-09-20
00888937014600MARSMARS 1800 IVF WS 6FT W/LEFT ELEC HEATWM1800LE2024-09-20
00888937014648MARSMARS 1800 MULTI ELEC WS 6FT ANTIVIBRATIONWM1800MPE2024-09-20
00888937014655TITANTITAN IVF FIXED STAND 75-80CMWTIVFE2024-09-20
00888937014662TITANTITAN WTIVFEADJ IVF 120V SERIAL NUMBERWTIVFEADJ-W51202024-09-20
00888937014679TITANTITAN IVF ADJUSTABLE HEIGHTWTIVFEADJ2024-09-20
00888937020243MARSMARS 900E IVF 240V SERIAL NUMBERWM900E-W52402024-09-20
00888937020281MARSMARS 1800LE IVF 240V SERIAL NUMBERWM1800DE-W52402024-09-20
00888937020298MARSMARS 1800LE IVF 240V SERIAL NUMBERWM1800LE-W52402024-09-20
00888937020304MARSMARS 1800LE IVF 240V SERIAL NUMBERWM1800MPE-W52402024-09-20
00888937020311MARSMARS 1800RE IVF 240V SERIAL NUMBERWM1800RE-W52402024-09-20
00888937020328TITANTITAN WTIVFE IVF 240V SERIAL NUMBERWTIVFE-W52402024-09-20
00888937020335TITANTITAN WTIVFEADJ IVF 240V SERIAL NUMBERWTIVFEADJ-W52402024-09-20
00888937024685MARSMARS 900 LAF 3FT MARS WORKSTATIONWM9002024-09-20
00888937024722TITANTITAN LAF BENCHTOP MODELWTLAF2024-09-20
05060554120024CODAK59549 Coda Inline Filter for G185 USK595492024-09-20
05060554120086G185K22400-110 G185 Standard 110V Incubator ROWK22400-1102024-09-20

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
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
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