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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 the device name listed in this FDA 510(k) record. The listed applicant is Medusa (Guangxi)Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2025-07-03 under 510(k) 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. The listed applicant is Medusa (Guangxi)Medical Devices Co., Ltd.. The 510(k) number is K243123.

When did IPL Treatment Device (MDSQMC-01) receive FDA 510(k) clearance?

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

Who is the listed applicant for IPL Treatment Device (MDSQMC-01)?

The FDA 510(k) record lists Medusa (Guangxi)Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: ONF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261204Intense Pulsed Light Therapy DeviceSanhe LEFIS Electronics Co., Ltd.K251545Intense Pulsed Light Therapy Device (MMABM-1)Micowey Medical Equipment (Guangxi) Co., Ltd.K231952MEDILIGHTMedicreations, LLCK250281DEKA LOTUSEl.En S.P.A.K242440Intense Pulsed Light Treatment System (LK-PT)Nanjing Bestview Laser S&T Co., Ltd.K240314MULA (K2-A1)Guangzhou Ciellulu Photoelectric Technology Co., 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.

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