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FDA 510(k)

Thulium Laser System (Deluxlase)

K-Number: K251919 · 2025-09-26

ApplicantNanjing Bestview Laser S&T Co., Ltd.
Decision Date2025-09-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Thulium Laser System (Deluxlase) is a medical device manufactured by Nanjing Bestview Laser S&T Co., Ltd.. It received FDA 510(k) clearance on 2025-09-26 under approval number K251919. 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 Thulium Laser System (Deluxlase)?

Thulium Laser System (Deluxlase) is a medical device that received FDA 510(k) clearance on 2025-09-26. It is manufactured by Nanjing Bestview Laser S&T Co., Ltd.. The 510(k) number is K251919.

When was Thulium Laser System (Deluxlase) approved by the FDA?

Thulium Laser System (Deluxlase) received FDA 510(k) clearance on 2025-09-26, under approval number K251919.

What company makes Thulium Laser System (Deluxlase)?

Thulium Laser System (Deluxlase) is manufactured by Nanjing Bestview Laser S&T Co., Ltd..

What is the FDA product code for Thulium Laser System (Deluxlase)?

The FDA product code for Thulium Laser System (Deluxlase) is GEX. This falls under the Gastroenterology category.

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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 Nanjing Bestview Laser S&T Co., Ltd.

K242440Intense Pulsed Light Treatment System (LK-PT) K250465CO2 Laser Machine (Lume) K260974CO2 Laser Machine (Monica-I,Monica-II) K260153Q-Switched Nd: YAG Laser System (Glamor Q)

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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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