Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ALPHAXENON LIGHT 180 W AND 300 W

K-Number: K093125 · 2010-01-27

ApplicantGimmi GmbH
Decision Date2010-01-27
Product CodeGCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ALPHAXENON LIGHT 180 W AND 300 W is the device name listed in this FDA 510(k) record. The listed applicant is Gimmi GmbH. It received FDA 510(k) clearance on 2010-01-27 under 510(k) number K093125. The device is classified under product code GCT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ALPHAXENON LIGHT 180 W AND 300 W?

ALPHAXENON LIGHT 180 W AND 300 W is a medical device that received FDA 510(k) clearance on 2010-01-27. The listed applicant is Gimmi GmbH. The 510(k) number is K093125.

When did ALPHAXENON LIGHT 180 W AND 300 W receive FDA 510(k) clearance?

ALPHAXENON LIGHT 180 W AND 300 W received FDA 510(k) clearance on 2010-01-27, under 510(k) number K093125.

Who is the listed applicant for ALPHAXENON LIGHT 180 W AND 300 W?

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

What is the FDA product code for ALPHAXENON LIGHT 180 W AND 300 W?

The FDA product code for ALPHAXENON LIGHT 180 W AND 300 W is GCT.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Gimmi 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.

K261179AlphaTriPart - Monopolar MIC InstrumentsK092421ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTICK081640GIMMI ANEURYSM CLIPS AND APPLYING FORCEPSK012869GIMMI ALPHA HYSTEROSCOPES & ACCESSORIES, MODELS E.8XXX.XX, T.8XXX.XX, ZXXX.XX,S.XXXX.XX, K0142.25K012660GIMMI'ALPHA' ENDOSCOPES & ACCESSORIESK013731GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03

View all 7 devices →

Related Devices (Code: GCT)

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.

K082925XENON-100 SCB LIGHT SOURCE, MODEL 20132620KARL STORZ Endoscopy-America, Inc.K070376CONMED LINVATEC 300W XENON LIGHT SOURCEConmed LinvatecK040949VIADUCT MINISCOPE AND ACCESSORIESAcueity, Inc.K022490KSEA MEDI PACKKARL STORZ Endoscopy-America, Inc.K031994LINVATEC 300W XENON LIGHT SOURCELinvatec Corp.K023468ENDOSCOPIC LIGHT SOURCE XL180/L3World of Medicine Lemke GmbH

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.

↑