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FDA 510(k)

PALOMAR DERMALUX PULSED LIGHT SYSTEM

K-Number: K010618 · 2001-09-10

ApplicantPalomar
Decision Date2001-09-10
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PALOMAR DERMALUX PULSED LIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Palomar. It received FDA 510(k) clearance on 2001-09-10 under 510(k) number K010618. 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 DERMALUX PULSED LIGHT SYSTEM?

PALOMAR DERMALUX PULSED LIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 2001-09-10. The listed applicant is Palomar. The 510(k) number is K010618.

When did PALOMAR DERMALUX PULSED LIGHT SYSTEM receive FDA 510(k) clearance?

PALOMAR DERMALUX PULSED LIGHT SYSTEM received FDA 510(k) clearance on 2001-09-10, under 510(k) number K010618.

Who is the listed applicant for PALOMAR DERMALUX PULSED LIGHT SYSTEM?

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 DERMALUX PULSED LIGHT SYSTEM?

The FDA product code for PALOMAR DERMALUX PULSED LIGHT SYSTEM 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.

K020941PALOMAR LUXG HANDPIECE

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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