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FDA 510(k)

FRAXEL II SR LASER SYSTEM

K-Number: K062303 · 2007-01-31

ApplicantReliant Technologies, Inc.
Decision Date2007-01-31
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

FRAXEL II SR LASER SYSTEM 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 2007-01-31 under 510(k) number K062303. 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?

FRAXEL II SR LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-01-31. The listed applicant is Reliant Technologies, Inc.. The 510(k) number is K062303.

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

FRAXEL II SR LASER SYSTEM received FDA 510(k) clearance on 2007-01-31, under 510(k) number K062303.

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

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?

The FDA product code for FRAXEL II SR LASER SYSTEM 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.

K080915FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIESK071051FRAXEL III SR LASER SYSTEM AND ACCESSORIESK071621RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIESK070284FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM)K063038FRAXEL III SR LASER SYSTEM AND ACCESSORIESK063808FRAXEL IV SR LASER SYSTEM

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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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