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FDA 510(k)

Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6

K-Number: K102050 · 2010-07-29

ApplicantAdvanced Technology Laser Co., Ltd.
Decision Date2010-07-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Technology Laser Co., Ltd.. It received FDA 510(k) clearance on 2010-07-29 under 510(k) number K102050. 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, MODEL GLOBALCURE-SC6?

Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 is a medical device that received FDA 510(k) clearance on 2010-07-29. The listed applicant is Advanced Technology Laser Co., Ltd.. The 510(k) number is K102050.

When did Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 receive FDA 510(k) clearance?

Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 received FDA 510(k) clearance on 2010-07-29, under 510(k) number K102050.

Who is the listed applicant for Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6?

The FDA 510(k) record lists Advanced Technology Laser Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6?

The FDA product code for Q-SWITCHED ND:YAG LASER SYSTEM, MODEL GLOBALCURE-SC6 is GEX. This falls under the Gastroenterology category.

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Other records listing Advanced Technology Laser Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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