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 Therapy Device (MMABM-1)

K-Number: K251545 · 2025-09-04

ApplicantMicowey Medical Equipment (Guangxi) Co., Ltd.
Decision Date2025-09-04
Product CodeONF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Intense Pulsed Light Therapy Device (MMABM-1) is a medical device manufactured by Micowey Medical Equipment (Guangxi) Co., Ltd.. It received FDA 510(k) clearance on 2025-09-04 under approval number K251545. 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 (MMABM-1)?

Intense Pulsed Light Therapy Device (MMABM-1) is a medical device that received FDA 510(k) clearance on 2025-09-04. It is manufactured by Micowey Medical Equipment (Guangxi) Co., Ltd.. The 510(k) number is K251545.

When was Intense Pulsed Light Therapy Device (MMABM-1) approved by the FDA?

Intense Pulsed Light Therapy Device (MMABM-1) received FDA 510(k) clearance on 2025-09-04, under approval number K251545.

What company makes Intense Pulsed Light Therapy Device (MMABM-1)?

Intense Pulsed Light Therapy Device (MMABM-1) is manufactured by Micowey Medical Equipment (Guangxi) Co., Ltd..

What is the FDA product code for Intense Pulsed Light Therapy Device (MMABM-1)?

The FDA product code for Intense Pulsed Light Therapy Device (MMABM-1) is ONF.

Related Clinical Trials

NCT07372677 Pocket-X Gel Non-surgical Periodontal Therapy RECRUITING NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT07614373 Virtual Reality-based Mindfulness Training for Mental Health After Stroke NOT_YET_RECRUITING NCT07614568 Evaluating the Efficacy and Safety of Octane Aether for Treating Chronic Low Back Pain NOT_YET_RECRUITING NCT07615569 Robot-assisted Versus Conventional Physical Therapy for Hand in Sub-acute Stroke RECRUITING NCT05313555 The Effect of Violet Device Dosed Ultra Violet-C Light (UV-C) Exposure on Healthy Hand Skin TERMINATED

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)

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.

↑