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FDA 510(k)

Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)

K-Number: K251076 · 2025-07-30

ApplicantShenzhen Lifotronic Technology Co., Ltd.
Decision Date2025-07-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) is a medical device manufactured by Shenzhen Lifotronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-30 under approval number K251076. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)?

Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) is a medical device that received FDA 510(k) clearance on 2025-07-30. It is manufactured by Shenzhen Lifotronic Technology Co., Ltd.. The 510(k) number is K251076.

When was Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) approved by the FDA?

Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) received FDA 510(k) clearance on 2025-07-30, under approval number K251076.

What company makes Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)?

Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) is manufactured by Shenzhen Lifotronic Technology Co., Ltd..

What is the FDA product code for Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)?

The FDA product code for Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

NCT07606729 AI-Driven Programs for Non-specific Chronic Neck Pain ACTIVE_NOT_RECRUITING NCT07607028 Comparison of Ultrasonic vs 980-nm Diode Laser Irrigant Activation for Reducing Residual Bacterial DNA in Necrotic Teeth COMPLETED NCT07595848 Integration of Wearable Sensor Devices Into a Single System to Predict the Onset of Sepsis NOT_YET_RECRUITING NCT07595198 Platelet-Rich Fibrin (PRF) vs Bone Graft With Membrane for Ridge Preservation After Tooth Extraction NOT_YET_RECRUITING NCT07593508 Diode Laser-Assisted Direct Pulp Capping Trial COMPLETED NCT02603640 " Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy COMPLETED

Related PubMed Literature

PMID: 41644679 Scaling medical device regulatory science using large language models. NPJ digital medicine (2026) PMID: 40978510 Federated learning: a privacy-preserving approach to data-centric regulatory cooperation. Frontiers in drug safety and regulation (2025) PMID: 40972375 AI-based EEG analysis: new technology and the path to clinical adoption. Clinical neurophysiology : official journal of the International Federation of Clinical Neurophysiology (2025)

Other Devices by Shenzhen Lifotronic Technology Co., Ltd.

K192466Air Compression Therapy System

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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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