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FDA 510(k)

Q-Switched Nd: YAG Laser System (Glamor Q)

K-Number: K260153 · 2026-04-20

ApplicantNanjing Bestview Laser S&T Co., Ltd.
Decision Date2026-04-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Q-Switched Nd: YAG Laser System (Glamor Q) is a medical device manufactured by Nanjing Bestview Laser S&T Co., Ltd.. It received FDA 510(k) clearance on 2026-04-20 under approval number K260153. 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 Q-Switched Nd: YAG Laser System (Glamor Q)?

Q-Switched Nd: YAG Laser System (Glamor Q) is a medical device that received FDA 510(k) clearance on 2026-04-20. It is manufactured by Nanjing Bestview Laser S&T Co., Ltd.. The 510(k) number is K260153.

When was Q-Switched Nd: YAG Laser System (Glamor Q) approved by the FDA?

Q-Switched Nd: YAG Laser System (Glamor Q) received FDA 510(k) clearance on 2026-04-20, under approval number K260153.

What company makes Q-Switched Nd: YAG Laser System (Glamor Q)?

Q-Switched Nd: YAG Laser System (Glamor Q) is manufactured by Nanjing Bestview Laser S&T Co., Ltd..

What is the FDA product code for Q-Switched Nd: YAG Laser System (Glamor Q)?

The FDA product code for Q-Switched Nd: YAG Laser System (Glamor Q) 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) K251919Thulium Laser System (Deluxlase) K250465CO2 Laser Machine (Lume) K260974CO2 Laser Machine (Monica-I,Monica-II)

Related Devices (Code: GEX)

K162114Photon, Photon PlusZolar Technology & Mfg Co., Inc. K161632FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)Bios S.R.L. K163222Discovery Pico FamilyQuanta System Spa K163009LithoQuanta System Spa K162191NAVILAS Laser SystemOd-Os GmbH K162363V30 system, V-Form Handpiece BC Medium applicatorViora , 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.

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