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FDA 510(k)

MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER

K-Number: K014234 · 2002-01-17

ApplicantContinuum Electro-Optics, Inc.
Decision Date2002-01-17
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER is the device name listed in this FDA 510(k) record. The listed applicant is Continuum Electro-Optics, Inc.. It received FDA 510(k) clearance on 2002-01-17 under 510(k) number K014234. 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 IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER?

MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER is a medical device that received FDA 510(k) clearance on 2002-01-17. The listed applicant is Continuum Electro-Optics, Inc.. The 510(k) number is K014234.

When did MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER receive FDA 510(k) clearance?

MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER received FDA 510(k) clearance on 2002-01-17, under 510(k) number K014234.

Who is the listed applicant for MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER?

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

What is the FDA product code for MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER?

The FDA product code for MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Continuum Electro-Optics, Inc. as applicant

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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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