Saturn Active Laser System
FDA 510(k) K083208 · Research Instruments , Ltd.
510(k) numberK083208
Submission
- Device name
- Saturn Active Laser System
- Applicant
- Research Instruments , Ltd.
Falmouth, Cornwall, GB - Received
- October 31, 2008
- Decision date
- August 25, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MRX – System, Assisted Reproduction Laser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.6200
- Specialty
- Obstetrics/Gynecology
This system is inteded to be used to drill a small tangential hole in or to thin the zona pellucida of the embryo in selected in vitro fertilization patients with otherwise poor prognois for successful pregnancy outcome, such as advanced maternal age, prior failed in vitro fertilization procedures, cryopreserved embryos, or abnormal zona pellucida morphology.
Other 510(k)s with product code MRX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253333 | Assisted Reproduction Laser System (Model ILS-400M)MRX · Traditional | Hua Yue Medical Technology Co., Ltd. | 06/17/2026SE |
| K202241 | LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)MRX · Traditional | Hamilton Thorne, Inc. | 07/02/2021SE |
| K192008 | LaserShot M, NaviLaseMRX · Abbreviated | Vitrolife GmbH | 03/25/2020SE |
| K141434 | Saturn 5 LaserMRX · Traditional | Research Instruments , Ltd. | 02/18/2015SE |
| K120055 | Hanilton Thorne Infrared Laser Optical System-Zilos-Tk Hamilton Thorne Infrared Laser…MRX · Traditional | Hamilton Thorne, Inc. | 04/24/2012SE |
| K063636 | Zilos-TkMRX · Traditional | Hamilton Thorne Biosciences | 04/24/2007SE |
| K060764 | Saturn 3 Laser SystemMRX · Traditional | Research Instruments , Ltd. | 03/12/2007SE |
| K062524 | Octax Laser Shot SystemMRX · Abbreviated | Minitube of America, Inc. | 12/15/2006SE |
| K050768 | Zilos-Tk, Version 3, Zilos-Tk, Version 4MRX · Special | Hamilton Thorne Biosciences | 04/28/2005SE |
More from Hamilton Thorne Biosciences
| 510(k) | Device | Decision |
|---|---|---|
| K161275 | EZ-Tip Singles, EZ-Tip Vial of 20, EZ-GripMQH · Traditional | 01/23/2017SE |
| K160504 | RI Witness Embryology Heated PlateMQG · Traditional | 07/18/2016SE |
| K141434 | Saturn 5 LaserMRX · Traditional | 02/18/2015SE |
| K133257 | Biopsy PipettesMQH · Traditional | 05/16/2014SE |
| K112413 | Ri MSC (Migration Sedimentation Chamber)MQK · Traditional | 07/13/2012SE |
| K060764 | Saturn 3 Laser SystemMRX · Traditional | 03/12/2007SE |
| K003142 | MicromanipulatorMQJ · Traditional | 11/22/2000SE |
| K991261 | Icsi Injection Micropipette (Spiked & Non-Spiked), Icsi Holding Miceopipette, Assisted…MQH · Traditional | 08/05/1999SE |
Questions and answers
When was Saturn Active Laser System cleared by the FDA?
Saturn Active Laser System (K083208) received a 510(k) decision of Substantially Equivalent on August 25, 2009, 298 days after the submission was received.
What is the product code of K083208?
The FDA product code is MRX – System, Assisted Reproduction Laser, a Class II (moderate risk) device regulated under 21 CFR 884.6200.