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FDA 510(k)

LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM

K-Number: K063427 · 2007-07-25

ApplicantLynton Lasers Limited
Decision Date2007-07-25
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Lynton Lasers Limited. It received FDA 510(k) clearance on 2007-07-25 under 510(k) number K063427. 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 LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM?

LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM is a medical device that received FDA 510(k) clearance on 2007-07-25. The listed applicant is Lynton Lasers Limited. The 510(k) number is K063427.

When did LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM receive FDA 510(k) clearance?

LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM received FDA 510(k) clearance on 2007-07-25, under 510(k) number K063427.

Who is the listed applicant for LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM?

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

What is the FDA product code for LUMINA INTENSE PULSED LIGHT (& LASER) SYSTEM?

The FDA product code for LUMINA INTENSE PULSED LIGHT (& LASER) 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 Lynton Lasers Limited 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.

K072048LUMACARE MODEL LC-122M NON-COHERENT LIGHT SOURCE AND MODEL LUM-P FIBRE OPTIC PROBEK062871LUMACARE LC-122M NON-COHERENT LIGHT SOURCE

Related Devices (Code: GEX)

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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