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)

Intense Pulsed Light Treatment System (LK-PT)

K-Number: K242440 · 2024-11-14

ApplicantNanjing Bestview Laser S&T Co., Ltd.
Decision Date2024-11-14
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense Pulsed Light Treatment System (LK-PT) is a medical device manufactured by Nanjing Bestview Laser S&T Co., Ltd.. It received FDA 510(k) clearance on 2024-11-14 under approval number K242440. The device is classified under product code ONF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Intense Pulsed Light Treatment System (LK-PT)?

Intense Pulsed Light Treatment System (LK-PT) is a medical device that received FDA 510(k) clearance on 2024-11-14. It is manufactured by Nanjing Bestview Laser S&T Co., Ltd.. The 510(k) number is K242440.

When was Intense Pulsed Light Treatment System (LK-PT) approved by the FDA?

Intense Pulsed Light Treatment System (LK-PT) received FDA 510(k) clearance on 2024-11-14, under approval number K242440.

What company makes Intense Pulsed Light Treatment System (LK-PT)?

Intense Pulsed Light Treatment System (LK-PT) is manufactured by Nanjing Bestview Laser S&T Co., Ltd..

What is the FDA product code for Intense Pulsed Light Treatment System (LK-PT)?

The FDA product code for Intense Pulsed Light Treatment System (LK-PT) is ONF.

Related Clinical Trials

NCT07614997 Effectiveness and Safety of the Ulthera® System for Skin Laxity in the Lower Face, Submentum and Neck NOT_YET_RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT06762717 FARAPULSE™ Pulsed Field Ablation System RECRUITING NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT07499128 Continuous Temperature Monitoring (CTM) for Cytokine Release Syndrome (CRS), an Immune-Related Adverse Event ENROLLING_BY_INVITATION NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED

Related PubMed Literature

PMID: 41251011 Effectivity of the Dehydrated Human Amnion/Chorion Membrane Allograft for Diabetic Foot Ulcers in Japan: A Case Series. International wound journal (2025) PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (2025) PMID: 40258332 Chronic expanding hematoma following Gamma Knife irradiation for primary central nervous system lymphoma: illustrative case. Journal of neurosurgery. Case lessons (2025)

Other Devices by Nanjing Bestview Laser S&T Co., Ltd.

K251919Thulium Laser System (Deluxlase) K250465CO2 Laser Machine (Lume) K260974CO2 Laser Machine (Monica-I,Monica-II) K260153Q-Switched Nd: YAG Laser System (Glamor Q)

Related Devices (Code: ONF)

K161565DUOStetic Medical Aesthetics Development (Shenzhen) Co. ,Ltd K161286IPL Therapy MachineBeijing Adss Development Co., Ltd. K160195Forma System, Forma Light SystemFormatk Systems , Ltd. K153717Venus Versa SystemVenus Concept , Ltd. K152790Venus Versa SystemVenus Concept , Ltd. K181868SHINY RPL SystemIds, Ltd.

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.

↑