LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
FDA 510(k) K202241 · Hamilton Thorne, Inc.
510(k) numberK202241
Submission
- Device name
- LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)
- Applicant
- Hamilton Thorne, Inc.
Beverly, MA, US - Received
- August 10, 2020
- Decision date
- July 2, 2021
- 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 |
| 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 |
| 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 |
|---|---|---|
| K192503 | GM501 Wash with Phenol Red and GentamicinMQL · Special | 11/19/2020SE |
| K192644 | GM501 SpermAir and GM501 SpermActiveMQL · Traditional | 04/23/2020SE |
| K191552 | GM501 Mineral OilMQL · Abbreviated | 09/18/2019SE |
| K190383 | GM501 WashMQL · Traditional | 09/05/2019SE |
| K120055 | Hanilton Thorne Infrared Laser Optical System-Zilos-Tk Hamilton Thorne Infrared Laser…MRX · Traditional | 04/24/2012SE |
Questions and answers
When was LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) cleared by the FDA?
LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) (K202241) received a 510(k) decision of Substantially Equivalent on July 2, 2021, 326 days after the submission was received.
What is the product code of K202241?
The FDA product code is MRX – System, Assisted Reproduction Laser, a Class II (moderate risk) device regulated under 21 CFR 884.6200.