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FDA 510(k)

Wrinkle Treatment Device (JM2)

K-Number: K240360 · 2024-04-05

ApplicantShenzhen Qianyu Technology Co., Ltd.
Decision Date2024-04-05
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Wrinkle Treatment Device (JM2) is a medical device manufactured by Shenzhen Qianyu Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-04-05 under approval number K240360. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Wrinkle Treatment Device (JM2)?

Wrinkle Treatment Device (JM2) is a medical device that received FDA 510(k) clearance on 2024-04-05. It is manufactured by Shenzhen Qianyu Technology Co., Ltd.. The 510(k) number is K240360.

When was Wrinkle Treatment Device (JM2) approved by the FDA?

Wrinkle Treatment Device (JM2) received FDA 510(k) clearance on 2024-04-05, under approval number K240360.

What company makes Wrinkle Treatment Device (JM2)?

Wrinkle Treatment Device (JM2) is manufactured by Shenzhen Qianyu Technology Co., Ltd..

What is the FDA product code for Wrinkle Treatment Device (JM2)?

The FDA product code for Wrinkle Treatment Device (JM2) is OHS.

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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)

Other Devices by Shenzhen Qianyu Technology Co., Ltd.

K220645Hand-held IPL device (JOVS Hair Removal Device) K214113Hand-held IPL device(JOVS Graphene Hair Removal Device) K231800IPL Hair Removal Device, Model(s): JP1, JR3, JR8, JR9 K250227JOVS Electric Stimulation Beauty Device (JE2) K244020Wrinkle Treatment Device (JM1, JM2B)

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Official Source

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

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