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FDA 510(k)

IPL Treatment Device (MDSQMC-01)

K-Number: K243123 · 2025-07-03

ApplicantMedusa (Guangxi)Medical Devices Co., Ltd.
Decision Date2025-07-03
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

IPL Treatment Device (MDSQMC-01) is a medical device manufactured by Medusa (Guangxi)Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2025-07-03 under approval number K243123. 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 IPL Treatment Device (MDSQMC-01)?

IPL Treatment Device (MDSQMC-01) is a medical device that received FDA 510(k) clearance on 2025-07-03. It is manufactured by Medusa (Guangxi)Medical Devices Co., Ltd.. The 510(k) number is K243123.

When was IPL Treatment Device (MDSQMC-01) approved by the FDA?

IPL Treatment Device (MDSQMC-01) received FDA 510(k) clearance on 2025-07-03, under approval number K243123.

What company makes IPL Treatment Device (MDSQMC-01)?

IPL Treatment Device (MDSQMC-01) is manufactured by Medusa (Guangxi)Medical Devices Co., Ltd..

What is the FDA product code for IPL Treatment Device (MDSQMC-01)?

The FDA product code for IPL Treatment Device (MDSQMC-01) is ONF.

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Related PubMed Literature

PMID: 41533265 Modernizing Medical Software Regulation in Bangladesh: A Roadmap for Risk-Based SaMD Oversight. Journal of medical systems (2026) PMID: 41448921 [Research on Standardized Testing Processes and Methods of Graphics Measurement Functions of Medical Device Software]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) 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: 41112966 Vascular Reconstruction Device for Coil Embolization of Wide-Neck Type Cerebral Aneurysm: Findings from a Post-Marketing Surveillance Study in Japan. Journal of neuroendovascular therapy (2025)

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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.

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