Octax NaviLase

Primary DI
04260604170028
Brand
Octax NaviLase
Company
Octax Microscience GmbH
Model
19310/0146
Catalog number
19310/0146
Device description
This submission includes two assisted reproduction laser systems, the LaserShot M and the NaviLase. The LaserShot M is a static laser system where the embryo is moved to the laser by moving the stage of the microscope. The LaserShot M components include a laser module (1.48 micrometer infrared diode laser, class 1M), laser adapter to connect to the microscope, mirror block, laser objective (25X), USB camera, EyeWare Software, and an optional target pointer and footswitch. The NaviLase includes the same components as the LaserShot M, but also includes a motion module and a motion controller. These additional components allow the NaviLase to work in two modes, fixed and dynamic. In fixed mode, the NaviLase operates similarly to the LaserShot M. In dynamic mode, the laser can be directed to any location within the field of view. In addition, dynamic mode allows automated laser firing along a user-defined path (straight line, arc, etc.). The EyeWare software controls the device components, operates the laser, and takes images and records videos of embryo undergoing laser procedures. The software determines how many holes are drilled along this line and controls/restricts laser firing parameters to minimize localized heating of the embryo during these procedures. These laser devices have been designed to be fitted to compatible inverted microscopes.
Published
2020-05-11
Public version status
New
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
K192008000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192008000LaserShot M, NaviLaseVitrolife GmbH2020-03-25MRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260604170028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260604170028042606041700284260604170028

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).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure735 millibar1060 millibar
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature-20 Degrees Celsius70 Degrees Celsius
Storage Environment Atmospheric Pressure735 millibar1060 millibar
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius70 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49876593990support.de@vitrolife.com

Regulatory Flags#

DUNS number
314169074
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260604170011Octax LaserShot M19310/0148M19310/0148M2020-05-11
04260502101483OCTAX Laser Shot19310/014819310/01482016-09-22

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
00858604006276ZILOS-tk™HAMILTON THORNE, INC.MRX2019-11-30
00858604006290LYKOS™HAMILTON THORNE, INC.MRX2019-11-30
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05060488043338Saturn 5 Laser SystemRESEARCH INSTRUMENTS LIMITEDMRX2018-02-23
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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