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FDA 510(k)

FOXQ 980 LASER

K-Number: K091059 · 2009-08-13

ApplicantA.R.C Laser GmbH
Decision Date2009-08-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FOXQ 980 LASER is the device name listed in this FDA 510(k) record. The listed applicant is A.R.C Laser GmbH. It received FDA 510(k) clearance on 2009-08-13 under 510(k) number K091059. 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 FOXQ 980 LASER?

FOXQ 980 LASER is a medical device that received FDA 510(k) clearance on 2009-08-13. The listed applicant is A.R.C Laser GmbH. The 510(k) number is K091059.

When did FOXQ 980 LASER receive FDA 510(k) clearance?

FOXQ 980 LASER received FDA 510(k) clearance on 2009-08-13, under 510(k) number K091059.

Who is the listed applicant for FOXQ 980 LASER?

The FDA 510(k) record lists A.R.C Laser GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOXQ 980 LASER?

The FDA product code for FOXQ 980 LASER 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 A.R.C Laser GmbH 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.

K220531FOX 810, FOX 980K192272Wolf445nmK170183Cetus system, Cetus probeK161403A.R.C. Laser Surgical Fibers and ProbesK073322FOX 1-980, FOX Q-1064, FOX-Q-810

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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