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FDA 510(k)

ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES

K-Number: K936198 · 1994-04-06

ApplicantCarl Zeiss, Inc.
Decision Date1994-04-06
Product CodeGCT
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES is the device name listed in this FDA 510(k) record. The listed applicant is Carl Zeiss, Inc.. It received FDA 510(k) clearance on 1994-04-06 under 510(k) number K936198. 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 ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES?

ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES is a medical device that received FDA 510(k) clearance on 1994-04-06. The listed applicant is Carl Zeiss, Inc.. The 510(k) number is K936198.

When did ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES receive FDA 510(k) clearance?

ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES received FDA 510(k) clearance on 1994-04-06, under 510(k) number K936198.

Who is the listed applicant for ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES?

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

What is the FDA product code for ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES?

The FDA product code for ZEISS SUPERLUX HIGH-INTENSITY LIGHT SOURCES is GCT.

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Other records listing Carl Zeiss, Inc. as applicant

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K013402VISULAS 532SK003885VISULAS YAG IIK993357IOLMASTERK983868OPMI TWINER SURGICAL MICROSCOPEK965139SURGICAL MICROSCOPE NAVIGATOR (SMN) SYSTEM/SURGICAL TOOL NAVIGATOR (STN) SYSTEMK961380CPC PROBE

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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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