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FDA 510(k)

FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES

K-Number: K080915 · 2008-07-01

ApplicantReliant Technologies, Inc.
Decision Date2008-07-01
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FRAXEL RE:PAIR (FRAXEL III 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 2008-07-01 under 510(k) number K080915. 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 RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES?

FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 2008-07-01. The listed applicant is Reliant Technologies, Inc.. The 510(k) number is K080915.

When did FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 2008-07-01, under 510(k) number K080915.

Who is the listed applicant for FRAXEL RE:PAIR (FRAXEL III 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 RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES?

The FDA product code for FRAXEL RE:PAIR (FRAXEL III 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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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