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FDA 510(k)

POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200

K-Number: K091962 · 2009-09-30

ApplicantLumenis, Inc.
Decision Date2009-09-30
Product CodeODF
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 2009-09-30 under 510(k) number K091962. The device is classified under product code ODF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200?

POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 is a medical device that received FDA 510(k) clearance on 2009-09-30. The listed applicant is Lumenis, Inc.. The 510(k) number is K091962.

When did POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 receive FDA 510(k) clearance?

POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 received FDA 510(k) clearance on 2009-09-30, under 510(k) number K091962.

Who is the listed applicant for POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200?

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

What is the FDA product code for POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200?

The FDA product code for POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200 is ODF.

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Other records listing Lumenis, 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.

K211979Lumenis Y&R Laser SystemK130195SCANNING LASERLINKK111213VISION ONE LASER SYSTEMK100228VERSAPULSE MODEL P20 LASER SYSTEMK082809ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEMK081704SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS

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Related Devices (Code: ODF)

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.

K092739MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILEC-Link Micro Imaging, Inc.K090170SPYSCOPE ACCESS AND DELIVERY CATHETERBoston Scientific CorpK052194SPYGLASS DIRECT VISUALIZATION PROBE AND OCULARBoston Scientific CorpK050403SPYGLASS DIRECT VISULATION PROBEBoston Scientific CorpK9633545 STAR MEDICAL ENDOSCOPEFive Star Medical, Inc.K943593SARATOGA MODULAR MINIATURE ENDOSCOPE SYSTEMOvamed 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.

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