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FDA 510(k)

PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER

K-Number: K020453 · 2002-05-10

ApplicantPalomar Medical Technologies, Inc.
Decision Date2002-05-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER 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 2002-05-10 under 510(k) number K020453. 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 ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER?

PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER is a medical device that received FDA 510(k) clearance on 2002-05-10. The listed applicant is Palomar Medical Technologies, Inc.. The 510(k) number is K020453.

When did PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER receive FDA 510(k) clearance?

PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER received FDA 510(k) clearance on 2002-05-10, under 510(k) number K020453.

Who is the listed applicant for PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER?

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 ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER?

The FDA product code for PALOMAR ESTELUX PULSED LIGHT SYSTEM AND PALOMAR COOLROLLER is GEX. This falls under the Gastroenterology category.

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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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