Saturn 5 Laser System
Saturn 5 is a microscope-based laser system for assisted-reproduction work, including assisted hatching and biopsy. It combines an ablation laser with a pilot laser that aligns the…
Saturn 5 is a microscope-based laser system for assisted-reproduction work, including assisted hatching and biopsy. It combines an ablation laser with a pilot laser that aligns the treatment beam.
Light is delivered through a fiber-optic lead into the microscope optical assembly. A camera and computer support targeting, image capture and control, with a motor module included in active versions.
Listed Item
Assisted Reproduction Laser
Fixed and Active Versions
Fixed and active models provide different beam-positioning configurations. RI Viewer software controls firing, measurements and image storage, while the active version includes a biopsy mode for a predefined path. An optional foot pedal provides another firing control.
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| HUA YUE Medical Technology Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 7 |
Record
| Listed by | Research Instruments Ltd, United Kingdom |
|---|---|
| FDA product code | MRX |
| Device type | System, Assisted Reproduction Laser |
| Device class | Class 2 |
| Regulation | 21 CFR 884.6200 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K141434 |
| Record published | 2018-02-23 |
| Record revised | 2024-02-28 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Saturn 5 Active Nikon TE300 40x | In distribution | |
| Saturn 5 Active Nikon TE2000 with Nikon XY Stage 40x | In distribution | |
| Saturn 5 Active Zeiss Axio Observer 20x LH | In distribution | |
| Saturn 5 Active Nikon TE2000 With Integra 40x | In distribution | |
| Saturn 5 Fixed Nikon TE300 40x | In distribution | |
| Saturn 5 Active Laser System with RI Viewer Software | In distribution | |
| Saturn 5 Active for Leica DMi8 20x | In distribution | |
| Saturn 5 Active – Nikon Ti with Nikon XY Stage 20x | In distribution | |
| Saturn 5 Active Nikon Diaphot200-300 | In distribution | |
| Saturn 5 Active Olympus IX50-70 | In distribution | |
| Saturn 5 Active – Nikon Ti with Integra 40x | In distribution | |
| Saturn 5 Active 20x Nikon Ti2 with Integra | In distribution | |
| Saturn 5 Active 20x Nikon Ti2 with Nikon XY Stage | In distribution | |
| Saturn 5 Active – Olympus IX3 20x | In distribution | |
| Saturn 5 Fixed Nikon TE2000 & Ti 40x | In distribution | |
| Saturn 5 Active – Nikon Ti with Nikon XY Stage 40x | In distribution | |
| Saturn 5 Laser System Fixed with RI Viewer Software | In distribution | |
| Saturn 5 Active Nikon TE2000 with Nikon XY Stage 20x | In distribution | |
| Saturn 5 Active – Nikon Ti with Integra 20x | In distribution | |
| Saturn 5 Active Zeiss Axio Observer 40x LH | In distribution | |
| Saturn 5 Active Nikon TE300 20x | In distribution | |
| Saturn 5 Active – Olympus IX3 40x | In distribution | |
| Saturn 5 Active Zeiss Axio Observer 20x RH | In distribution | |
| Saturn 5 Active 40x Nikon Ti2 with Nikon XY Stage | In distribution | |
| Saturn 5 Active Nikon TE2000 with Integra 20x | In distribution | |
| Saturn 5 Active Zeiss Axio Observer 40x RH | In distribution | |
| Saturn 5 Active Olympus IX2 20x RH | In distribution | |
| Saturn 5 Active Olympus IX2 40x RH | In distribution | |
| Saturn 5 Active Olympus IX2 20x LH | In distribution | |
| Saturn 5 Active for Leica DMi8 40x | In distribution | |
| Saturn 5 Fixed for Nikon Ti2 40x | In distribution | |
| Saturn 5 Active 40x Nikon Ti2 with Integra | In distribution | |
| Saturn 5 Active Olympus IX2 40x LH | In distribution | |
| Saturn 5 Fixed Leica DMi8 40x | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Octax LaserShot M | Octax Microscience GmbH | 1 |
| Lykos™ | Hamilton Thorne, Inc. | 1 |
| Lykos DTS | Hamilton Thorne, Inc. | 1 |
| Octax Laser Shot | Octax Microscience GmbH | 1 |
| ZILOS-tk™ | Hamilton Thorne, Inc. | 1 |
| Octax NaviLase | Octax Microscience GmbH | 1 |
| RI Saturn | Research Instruments Ltd | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K141434 | 2015-02-18 |
| K083208 | 2009-08-25 |
| K060764 | 2007-03-12 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.