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)

COLDLIGHTSOURCE PL3000

K-Number: K993300 · 1999-11-05

ApplicantFiber Imaging Technologies, Inc.
Decision Date1999-11-05
Product CodeFCW
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLDLIGHTSOURCE PL3000 is the device name listed in this FDA 510(k) record. The listed applicant is Fiber Imaging Technologies, Inc.. It received FDA 510(k) clearance on 1999-11-05 under 510(k) number K993300. The device is classified under product code FCW. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COLDLIGHTSOURCE PL3000?

COLDLIGHTSOURCE PL3000 is a medical device that received FDA 510(k) clearance on 1999-11-05. The listed applicant is Fiber Imaging Technologies, Inc.. The 510(k) number is K993300.

When did COLDLIGHTSOURCE PL3000 receive FDA 510(k) clearance?

COLDLIGHTSOURCE PL3000 received FDA 510(k) clearance on 1999-11-05, under 510(k) number K993300.

Who is the listed applicant for COLDLIGHTSOURCE PL3000?

The FDA 510(k) record lists Fiber Imaging Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COLDLIGHTSOURCE PL3000?

The FDA product code for COLDLIGHTSOURCE PL3000 is FCW.

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 Fiber Imaging Technologies, 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.

K992527URETERO-RENOSCOPEK992437SCHOELLY RIGID ENDOSCOPESK992040FLEXISCOPE II ARTHROSCOPES AND ACCESSORIESK991560NASO-LARYNGO-PHARYNGOSCOPE

Related Devices (Code: FCW)

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.

K123956POWER LED 175KARL STORZ Endoscopy-America, Inc.K123359OVS1 VIDEO SYSTEMOlive Medical Corp.K121724ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2Richard Wolf Medical Instruments Corp.K093792LED LIGHT SOURCESunoptic Technologies, LLCK091968KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020CKARL STORZ Endoscopy-America, Inc.K082813STRYKER LED LIGHTSOURCEStryker Corp.

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.

↑