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FDA 510(k)

PALOMAR LUXG HANDPIECE

K-Number: K020941 · 2002-06-19

ApplicantPalomar
Decision Date2002-06-19
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PALOMAR LUXG HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Palomar. It received FDA 510(k) clearance on 2002-06-19 under 510(k) number K020941. 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 LUXG HANDPIECE?

PALOMAR LUXG HANDPIECE is a medical device that received FDA 510(k) clearance on 2002-06-19. The listed applicant is Palomar. The 510(k) number is K020941.

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

PALOMAR LUXG HANDPIECE received FDA 510(k) clearance on 2002-06-19, under 510(k) number K020941.

Who is the listed applicant for PALOMAR LUXG HANDPIECE?

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

What is the FDA product code for PALOMAR LUXG HANDPIECE?

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

Related Clinical Trials

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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Other records listing Palomar 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.

K010618PALOMAR DERMALUX PULSED LIGHT 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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