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FDA 510(k)

XENON LIGHT SOURCE PES 1

K-Number: K992540 · 1999-09-14

ApplicantLaser Optik Systeme GmbH & Co. KG
Decision Date1999-09-14
Product CodeGCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

XENON LIGHT SOURCE PES 1 is the device name listed in this FDA 510(k) record. The listed applicant is Laser Optik Systeme GmbH & Co. KG. It received FDA 510(k) clearance on 1999-09-14 under 510(k) number K992540. 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 XENON LIGHT SOURCE PES 1?

XENON LIGHT SOURCE PES 1 is a medical device that received FDA 510(k) clearance on 1999-09-14. The listed applicant is Laser Optik Systeme GmbH & Co. KG. The 510(k) number is K992540.

When did XENON LIGHT SOURCE PES 1 receive FDA 510(k) clearance?

XENON LIGHT SOURCE PES 1 received FDA 510(k) clearance on 1999-09-14, under 510(k) number K992540.

Who is the listed applicant for XENON LIGHT SOURCE PES 1?

The FDA 510(k) record lists Laser Optik Systeme GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XENON LIGHT SOURCE PES 1?

The FDA product code for XENON LIGHT SOURCE PES 1 is GCT.

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Other records listing Laser Optik Systeme GmbH & Co. KG 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.

K972056STANDARD ENDOSCOPEK950712PORTABLE ENDOSCOPY SYSTEMK953419LOS 3D VISION 100K952028COLD LIGHT SOURCE LOS XL-A 100K951829COLD LIGHT SOURCE LOS 150K930965LOS 3D VISION 100

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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.

K093125ALPHAXENON LIGHT 180 W AND 300 WGimmi GmbHK082925XENON-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.

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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