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FDA 510(k)

COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER

K-Number: K000498 · 2000-03-13

ApplicantLumenis, Inc.
Decision Date2000-03-13
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Inc.. It received FDA 510(k) clearance on 2000-03-13 under 510(k) number K000498. 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 COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER?

COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER is a medical device that received FDA 510(k) clearance on 2000-03-13. The listed applicant is Lumenis, Inc.. The 510(k) number is K000498.

When did COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER receive FDA 510(k) clearance?

COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER received FDA 510(k) clearance on 2000-03-13, under 510(k) number K000498.

Who is the listed applicant for COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER?

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 COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER?

The FDA product code for COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER is GEX. This falls under the Gastroenterology category.

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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 SYSTEMK091962POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-200K082809ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM

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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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