What is FDA product code MRX?

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.

Obstetrics & Gynecology › MiscellaneousSystem, Assisted Reproduction Laser

Lykos DTS

Name: Lykos DTS
Brand: Lykos DTS

LYKOS DTS is a laser system used in IVF laboratories to make a small tangential hole in, or thin, the outer zona pellucida of selected embryos during assisted hatching. It is also used to…

Registry build 21.09.26

LYKOS DTS is a laser system used in IVF laboratories to make a small tangential hole in, or thin, the outer zona pellucida of selected embryos during assisted hatching. It is also used to biopsy trophectoderm cells from blastocyst-stage embryos for preimplantation genetic diagnosis or screening.

A laser and motor-driven mirror assembly sit within a 40x objective mounted on an inverted microscope. A computer and camera show the live field of view. In DTS mode, the embryo stays stationary while the computer directs the beam along a path plotted by the user.

Aiming and Modes

The 1460 nm infrared beam is aligned with a visible red LED beam so its position can be checked before firing. Fixed direction mode instead keeps the beam stationary while the user moves the embryo. The system can record procedure images and video.

1manufacturer

1catalogue number

2510(k) clearances naming this product code

Who Else Makes It

Registered in Guangdong.

Chinese manufacturers registered for FDA product code MRX
Manufacturer	City	Province	Registered as	Device types
HUA YUE Medical Technology Co., Ltd.	Guangzhou	Guangdong	Manufacturer	7

Record

Regulatory record for Lykos DTS
Listed by	Hamilton Thorne, Inc., United States
FDA product code	MRX
Device type	System, Assisted Reproduction Laser
Device class	Class 2
Regulation	21 CFR 884.6200
Establishment	Specification developer, Complaint-file establishment, Manufacturer
510(k)	K202241
Record published	2023-06-07

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Label carries	manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Lykos DTS
Catalogue number	Size	Status
LYKOS DTS		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Saturn 5 Laser System	Research Instruments Ltd	34
Octax LaserShot M	Octax Microscience GmbH	1
Lykos™	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

FDA 510(k) clearances naming this product code
Clearance	Decision date
K202241	2021-07-02
K120055	2012-04-24

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.