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FDA 510(k)

Intense pulsed light therapy device

K-Number: K232708 · 2023-12-01

ApplicantHebei Zhemai Technology Co., Ltd.
Decision Date2023-12-01
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense pulsed light therapy device is a medical device manufactured by Hebei Zhemai Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-12-01 under approval number K232708. 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 therapy device?

Intense pulsed light therapy device is a medical device that received FDA 510(k) clearance on 2023-12-01. It is manufactured by Hebei Zhemai Technology Co., Ltd.. The 510(k) number is K232708.

When was Intense pulsed light therapy device approved by the FDA?

Intense pulsed light therapy device received FDA 510(k) clearance on 2023-12-01, under approval number K232708.

What company makes Intense pulsed light therapy device?

Intense pulsed light therapy device is manufactured by Hebei Zhemai Technology Co., Ltd..

What is the FDA product code for Intense pulsed light therapy device?

The FDA product code for Intense pulsed light therapy device is ONF.

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Related PubMed Literature

PMID: 41470022 Low-intensity pulsed ultrasound for peripheral nerve regeneration: mechanobiological mechanisms and translational potential. Journal of translational medicine (2025) PMID: 41072144 Use of Bayesian decision analysis in the design of patient-centered clinical trials for kidney failure devices. Computers in biology and medicine (2025) PMID: 41040861 Enhancing post-operative hypothyroidism treatment: rat thyroid autotransplantation into a pre-vascularized, retrievable cell pouch™ device. Frontiers in endocrinology (2025) PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (2025)

Other Devices by Hebei Zhemai Technology Co., Ltd.

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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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