Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)

K-Number: K202241 · 2021-07-02

ApplicantHamilton Thorne, Inc.
Decision Date2021-07-02
Product CodeMRX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) is a medical device manufactured by Hamilton Thorne, Inc.. It received FDA 510(k) clearance on 2021-07-02 under approval number K202241. The device is classified under product code MRX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) is a medical device that received FDA 510(k) clearance on 2021-07-02. It is manufactured by Hamilton Thorne, Inc.. The 510(k) number is K202241.

When was LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) approved by the FDA?

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) received FDA 510(k) clearance on 2021-07-02, under approval number K202241.

What company makes LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) is manufactured by Hamilton Thorne, Inc..

What is the FDA product code for LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

The FDA product code for LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) is MRX.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED NCT07616050 Evaluation of the Impact of Virtual Park on Training Motivation in Adult Patients NOT_YET_RECRUITING NCT07614581 Intra-Sessional Autonomic Arc Detection in Ketamine-Assisted Therapy for PTSD: A Signal Characterisation Pilot Study NOT_YET_RECRUITING NCT07615569 Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke RECRUITING NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41160299 Toward safe clinical deployment of remote robotic surgery in Japan: five-year validation of the hinotori™ system using 5G wireless communication. International journal of clinical oncology (2025) PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Hamilton Thorne, Inc.

K191552GM501 Mineral Oil K190383GM501 Wash

Related Devices (Code: MRX)

K192008LaserShot M, NaviLaseVitrolife GmbH

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑