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FDA 510(k)

PALOMAR LUXIR FRACTIONAL HANDPIECE

K-Number: K060069 · 2006-03-02

ApplicantPalomar Medical Technologies, Inc.
Decision Date2006-03-02
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PALOMAR LUXIR FRACTIONAL 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 2006-03-02 under 510(k) number K060069. 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 LUXIR FRACTIONAL HANDPIECE?

PALOMAR LUXIR FRACTIONAL HANDPIECE is a medical device that received FDA 510(k) clearance on 2006-03-02. The listed applicant is Palomar Medical Technologies, Inc.. The 510(k) number is K060069.

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

PALOMAR LUXIR FRACTIONAL HANDPIECE received FDA 510(k) clearance on 2006-03-02, under 510(k) number K060069.

Who is the listed applicant for PALOMAR LUXIR FRACTIONAL 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 LUXIR FRACTIONAL HANDPIECE?

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

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Other records listing Palomar Medical Technologies, Inc. as applicant

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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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