Saturn 3 Laser System
FDA 510(k) K060764 · Research Instruments , Ltd.
510(k) numberK060764
Submission
- Device name
- Saturn 3 Laser System
- Applicant
- Research Instruments , Ltd.
Irvine, CA, US - Received
- March 21, 2006
- Decision date
- March 12, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| K083208 | Saturn Active Laser SystemMRX · Abbreviated | Research Instruments , Ltd. | 08/25/2009SE |
| K063636 | Zilos-TkMRX · Traditional | Hamilton Thorne Biosciences | 04/24/2007SE |
| 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 |
| K083208 | Saturn Active Laser SystemMRX · Abbreviated | 08/25/2009SE |
| 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 3 Laser System cleared by the FDA?
Saturn 3 Laser System (K060764) received a 510(k) decision of Substantially Equivalent on March 12, 2007, 356 days after the submission was received.
What is the product code of K060764?
The FDA product code is MRX – System, Assisted Reproduction Laser, a Class II (moderate risk) device regulated under 21 CFR 884.6200.