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FDA 510(k)

PALOMAR LUX2940 HANDPIECE

K-Number: K063571 · 2007-02-09

ApplicantPalomar Medical Technologies, Inc.
Decision Date2007-02-09
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PALOMAR LUX2940 HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Palomar Medical Technologies, Inc.. It received FDA 510(k) clearance on 2007-02-09 under 510(k) number K063571. 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 PALOMAR LUX2940 HANDPIECE?

PALOMAR LUX2940 HANDPIECE is a medical device that received FDA 510(k) clearance on 2007-02-09. The listed applicant is Palomar Medical Technologies, Inc.. The 510(k) number is K063571.

When did PALOMAR LUX2940 HANDPIECE receive FDA 510(k) clearance?

PALOMAR LUX2940 HANDPIECE received FDA 510(k) clearance on 2007-02-09, under 510(k) number K063571.

Who is the listed applicant for PALOMAR LUX2940 HANDPIECE?

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

What is the FDA product code for PALOMAR LUX2940 HANDPIECE?

The FDA product code for PALOMAR LUX2940 HANDPIECE is GEX. This falls under the Gastroenterology category.

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Other records listing Palomar Medical 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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