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FDA 510(k)

FRAXEL II SR LASER SYSTEM AND ACCESSORIES

K-Number: K060310 · 2006-03-29

ApplicantReliant Technologies, Inc.
Decision Date2006-03-29
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FRAXEL II SR LASER SYSTEM AND ACCESSORIES 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 2006-03-29 under 510(k) number K060310. 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 FRAXEL II SR LASER SYSTEM AND ACCESSORIES?

FRAXEL II SR LASER SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2006-03-29. The listed applicant is Reliant Technologies, Inc.. The 510(k) number is K060310.

When did FRAXEL II SR LASER SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

FRAXEL II SR LASER SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 2006-03-29, under 510(k) number K060310.

Who is the listed applicant for FRAXEL II SR LASER SYSTEM AND ACCESSORIES?

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 FRAXEL II SR LASER SYSTEM AND ACCESSORIES?

The FDA product code for FRAXEL II SR LASER SYSTEM AND ACCESSORIES 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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