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FDA 510(k)

LUMENIS 1000 INTEGRATED SLIT LAMP

K-Number: K052129 · 2005-08-30

ApplicantLumenis, Inc.
Decision Date2005-08-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUMENIS 1000 INTEGRATED SLIT LAMP is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 2005-08-30 under 510(k) number K052129. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMENIS 1000 INTEGRATED SLIT LAMP?

LUMENIS 1000 INTEGRATED SLIT LAMP is a medical device that received FDA 510(k) clearance on 2005-08-30. The listed applicant is Lumenis, Inc.. The 510(k) number is K052129.

When did LUMENIS 1000 INTEGRATED SLIT LAMP receive FDA 510(k) clearance?

LUMENIS 1000 INTEGRATED SLIT LAMP received FDA 510(k) clearance on 2005-08-30, under 510(k) number K052129.

Who is the listed applicant for LUMENIS 1000 INTEGRATED SLIT LAMP?

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 LUMENIS 1000 INTEGRATED SLIT LAMP?

The FDA product code for LUMENIS 1000 INTEGRATED SLIT LAMP is GEX. This falls under the Gastroenterology category.

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Other records listing Lumenis, Inc. as applicant

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Related Devices (Code: GEX)

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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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