Octax LaserShot M
Basic Information
- Brand Name
- Octax LaserShot M
- Primary DI
- 04260604170011
- Version / Model
- 19310/0148M
- Catalog Number
- 19310/0148M
- Company Name
- Octax Microscience GmbH
- Labeler DUNS
- 314169074
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-05-11
- Public Version
- 1
- Public Version Date
- 2020-05-19
- Public Version Status
- New
- Public Device Record Key
- 7ba123cb-3c78-4dd1-9c7f-4640fa05d7ee
Device Description
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 microm infrared diode laser, class 1M), laser adapter to connect to the microscope, mirror block, laser objective (25 times), USB camera, Eye Ware Software, and an optional target pointer and foot switch. 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.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| MRX | System, Assisted Reproduction Laser | Obstetrics/Gynecology | 884.6200 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 61181 | Assisted reproduction laser system | A 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). | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04260604170011 | GS1 |
Customer Contacts
- Phone
- +49876593990
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192008 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 735 – 1060 millibar
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 735 – 1060 millibar
- Type
- Handling Environment Humidity
- Temperature Range
- 20 – 80 Percent (%) Relative Humidity
- Type
- Handling Environment Temperature
- Temperature Range
- -20 – 70 Degrees Celsius