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FDA 510(k)

MEDLITE/755 ALEXANDRITE LASER SYSTEM

K-Number: K961006 · 1996-09-11

ApplicantContinuum Biomedical, Inc.
Decision Date1996-09-11
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDLITE/755 ALEXANDRITE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Continuum Biomedical, Inc.. It received FDA 510(k) clearance on 1996-09-11 under 510(k) number K961006. 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 MEDLITE/755 ALEXANDRITE LASER SYSTEM?

MEDLITE/755 ALEXANDRITE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 1996-09-11. The listed applicant is Continuum Biomedical, Inc.. The 510(k) number is K961006.

When did MEDLITE/755 ALEXANDRITE LASER SYSTEM receive FDA 510(k) clearance?

MEDLITE/755 ALEXANDRITE LASER SYSTEM received FDA 510(k) clearance on 1996-09-11, under 510(k) number K961006.

Who is the listed applicant for MEDLITE/755 ALEXANDRITE LASER SYSTEM?

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

What is the FDA product code for MEDLITE/755 ALEXANDRITE LASER SYSTEM?

The FDA product code for MEDLITE/755 ALEXANDRITE LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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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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