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FDA 510(k)

MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER

K-Number: K973719 · 1997-12-23

ApplicantContinuum Biomedical, Inc.
Decision Date1997-12-23
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER 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 1997-12-23 under 510(k) number K973719. 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 Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER?

MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER is a medical device that received FDA 510(k) clearance on 1997-12-23. The listed applicant is Continuum Biomedical, Inc.. The 510(k) number is K973719.

When did MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER receive FDA 510(k) clearance?

MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER received FDA 510(k) clearance on 1997-12-23, under 510(k) number K973719.

Who is the listed applicant for MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER?

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 Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER?

The FDA product code for MEDLITE Q-SWITCHED ND:YAG LASER, MEDLITE IV Q-SWITCHED ND:YAG LASER 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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