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FDA 510(k)

MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM

K-Number: K060234 · 2006-03-15

ApplicantMccue Plc
Decision Date2006-03-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mccue Plc. It received FDA 510(k) clearance on 2006-03-15 under 510(k) number K060234. 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 MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM?

MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-15. The listed applicant is Mccue Plc. The 510(k) number is K060234.

When did MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM receive FDA 510(k) clearance?

MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM received FDA 510(k) clearance on 2006-03-15, under 510(k) number K060234.

Who is the listed applicant for MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM?

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

What is the FDA product code for MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM?

The FDA product code for MCCUE ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Mccue Plc 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.

K040659MCCUE PLC ENERGIST ULTRA VARIABLE PULSED LIGHT SYSTEM

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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