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FDA 510(k)

SurgiLight 1470 Diode Laser System (Model:Halo)

K-Number: K251049 · 2025-07-02

ApplicantMicro-Energy Medical Technology Co., Ltd.
Decision Date2025-07-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SurgiLight 1470 Diode Laser System (Model:Halo) is a medical device manufactured by Micro-Energy Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-07-02 under approval number K251049. 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 SurgiLight 1470 Diode Laser System (Model:Halo)?

SurgiLight 1470 Diode Laser System (Model:Halo) is a medical device that received FDA 510(k) clearance on 2025-07-02. It is manufactured by Micro-Energy Medical Technology Co., Ltd.. The 510(k) number is K251049.

When was SurgiLight 1470 Diode Laser System (Model:Halo) approved by the FDA?

SurgiLight 1470 Diode Laser System (Model:Halo) received FDA 510(k) clearance on 2025-07-02, under approval number K251049.

What company makes SurgiLight 1470 Diode Laser System (Model:Halo)?

SurgiLight 1470 Diode Laser System (Model:Halo) is manufactured by Micro-Energy Medical Technology Co., Ltd..

What is the FDA product code for SurgiLight 1470 Diode Laser System (Model:Halo)?

The FDA product code for SurgiLight 1470 Diode Laser System (Model:Halo) is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

Other Devices by Micro-Energy Medical Technology Co., Ltd.

K252745Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)

Related Devices (Code: GEX)

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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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