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FDA 510(k)

ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM

K-Number: K082825 · 2009-02-06

ApplicantEnergist, Ltd.
Decision Date2009-02-06
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Energist, Ltd.. It received FDA 510(k) clearance on 2009-02-06 under 510(k) number K082825. 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 ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM?

ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM is a medical device that received FDA 510(k) clearance on 2009-02-06. The listed applicant is Energist, Ltd.. The 510(k) number is K082825.

When did ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM receive FDA 510(k) clearance?

ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM received FDA 510(k) clearance on 2009-02-06, under 510(k) number K082825.

Who is the listed applicant for ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM?

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

What is the FDA product code for ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM?

The FDA product code for ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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Other records listing Energist, Ltd. 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.

K132754NEOGEN PSR SYSTEMK060216ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM

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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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