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FDA 510(k)

COLD LIGHT SOURCE LOS XL-A 100

K-Number: K952028 · 1995-07-27

ApplicantLaser-Optik-Systeme GmbH & Co. KG
Decision Date1995-07-27
Product CodeGCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

COLD LIGHT SOURCE LOS XL-A 100 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 1995-07-27 under 510(k) number K952028. 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 COLD LIGHT SOURCE LOS XL-A 100?

COLD LIGHT SOURCE LOS XL-A 100 is a medical device that received FDA 510(k) clearance on 1995-07-27. The listed applicant is Laser-Optik-Systeme GmbH & Co. KG. The 510(k) number is K952028.

When did COLD LIGHT SOURCE LOS XL-A 100 receive FDA 510(k) clearance?

COLD LIGHT SOURCE LOS XL-A 100 received FDA 510(k) clearance on 1995-07-27, under 510(k) number K952028.

Who is the listed applicant for COLD LIGHT SOURCE LOS XL-A 100?

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 COLD LIGHT SOURCE LOS XL-A 100?

The FDA product code for COLD LIGHT SOURCE LOS XL-A 100 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.

K992540XENON LIGHT SOURCE PES 1K972056STANDARD ENDOSCOPEK950712PORTABLE ENDOSCOPY SYSTEMK953419LOS 3D VISION 100K951829COLD LIGHT SOURCE LOS 150K930965LOS 3D VISION 100

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.

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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