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FDA 510(k)

ACCUSCAN MODEL C CO2 LASER SCANNER

K-Number: K953670 · 1996-01-26

ApplicantReliant Technologies, Inc.
Decision Date1996-01-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ACCUSCAN MODEL C CO2 LASER SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Reliant Technologies, Inc.. It received FDA 510(k) clearance on 1996-01-26 under 510(k) number K953670. 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 ACCUSCAN MODEL C CO2 LASER SCANNER?

ACCUSCAN MODEL C CO2 LASER SCANNER is a medical device that received FDA 510(k) clearance on 1996-01-26. The listed applicant is Reliant Technologies, Inc.. The 510(k) number is K953670.

When did ACCUSCAN MODEL C CO2 LASER SCANNER receive FDA 510(k) clearance?

ACCUSCAN MODEL C CO2 LASER SCANNER received FDA 510(k) clearance on 1996-01-26, under 510(k) number K953670.

Who is the listed applicant for ACCUSCAN MODEL C CO2 LASER SCANNER?

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

What is the FDA product code for ACCUSCAN MODEL C CO2 LASER SCANNER?

The FDA product code for ACCUSCAN MODEL C CO2 LASER SCANNER is GEX. This falls under the Gastroenterology category.

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Other records listing Reliant Technologies, 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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