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FDA 510(k)

ENDOCOAGULATOR KRS568(TM) LASER

K-Number: K904700 · 1991-02-19

ApplicantHgm Medical Laser Systems, Inc.
Decision Date1991-02-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENDOCOAGULATOR KRS568(TM) LASER is the device name listed in this FDA 510(k) record. The listed applicant is Hgm Medical Laser Systems, Inc.. It received FDA 510(k) clearance on 1991-02-19 under 510(k) number K904700. 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 ENDOCOAGULATOR KRS568(TM) LASER?

ENDOCOAGULATOR KRS568(TM) LASER is a medical device that received FDA 510(k) clearance on 1991-02-19. The listed applicant is Hgm Medical Laser Systems, Inc.. The 510(k) number is K904700.

When did ENDOCOAGULATOR KRS568(TM) LASER receive FDA 510(k) clearance?

ENDOCOAGULATOR KRS568(TM) LASER received FDA 510(k) clearance on 1991-02-19, under 510(k) number K904700.

Who is the listed applicant for ENDOCOAGULATOR KRS568(TM) LASER?

The FDA 510(k) record lists Hgm Medical Laser Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENDOCOAGULATOR KRS568(TM) LASER?

The FDA product code for ENDOCOAGULATOR KRS568(TM) LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Hgm Medical Laser Systems, Inc. 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.

K921300MODEL PC ARGON ION LASERK914484LITESPOT(TM) LASER INDIRECT OPHTHALMOSCOPEK913569COMPAC A, ELITE A, ELITE A PLUS, SURGICA AK912628AIR ARGON ION LASERS VARIOUS MODELSK910272HGM COMBINATION ND:YAG & SOLID STATE GREENK912438MODELS 5,8,20,20S ARGON ION LASERS

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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.

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

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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