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FDA 510(k)

PALOMAR LUX 1540 HANDPIECE

K-Number: K080244 · 2008-06-20

ApplicantPalomar Medical Products, Inc.
Decision Date2008-06-20
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PALOMAR LUX 1540 HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Palomar Medical Products, Inc.. It received FDA 510(k) clearance on 2008-06-20 under 510(k) number K080244. 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 LUX 1540 HANDPIECE?

PALOMAR LUX 1540 HANDPIECE is a medical device that received FDA 510(k) clearance on 2008-06-20. The listed applicant is Palomar Medical Products, Inc.. The 510(k) number is K080244.

When did PALOMAR LUX 1540 HANDPIECE receive FDA 510(k) clearance?

PALOMAR LUX 1540 HANDPIECE received FDA 510(k) clearance on 2008-06-20, under 510(k) number K080244.

Who is the listed applicant for PALOMAR LUX 1540 HANDPIECE?

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

What is the FDA product code for PALOMAR LUX 1540 HANDPIECE?

The FDA product code for PALOMAR LUX 1540 HANDPIECE is GEX. This falls under the Gastroenterology category.

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Other records listing Palomar Medical Products, 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.

K111840EMERGE FRACTIONAL LASERK091446MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECEK092222THERMAPULSEK090525LOI SYSTEMK083900ERBIUM FRACTIONAL HANDPIECEK083165PALOMAR ASPIRE LASER PLATFORM

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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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