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FDA 510(k)

LASER-6

K-Number: K921096 · 1992-07-28

ApplicantLaser Endo Technic
Decision Date1992-07-28
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LASER-6 is the device name listed in this FDA 510(k) record. The listed applicant is Laser Endo Technic. It received FDA 510(k) clearance on 1992-07-28 under 510(k) number K921096. 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 LASER-6?

LASER-6 is a medical device that received FDA 510(k) clearance on 1992-07-28. The listed applicant is Laser Endo Technic. The 510(k) number is K921096.

When did LASER-6 receive FDA 510(k) clearance?

LASER-6 received FDA 510(k) clearance on 1992-07-28, under 510(k) number K921096.

Who is the listed applicant for LASER-6?

The FDA 510(k) record lists Laser Endo Technic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LASER-6?

The FDA product code for LASER-6 is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Laser Endo Technic 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.

K923050ND:YAG LASER-12

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.

K254199PicoreMax (PicoreMax)BLUECORE COMPANY Co., Ltd.K252723Dynamis Pro FamilyFotona D.O.O.K241973SmartIPL_NI SystemLumenis Be, Ltd.K261047Dental Diode Laser Device (Laser-Pen)Guilin Kevin Peter Technology Co., Ltd.K261817Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)Zhengzhou PZ Laser Slim Technology Co., Ltd.K261673LED Therapy Device (QLXY-01)Beijing Nubway S&T Co., Ltd.

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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