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FDA 510(k)

ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM

K-Number: K060216 · 2006-03-16

ApplicantEnergist, Ltd.
Decision Date2006-03-16
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ENERGIST ULTRA VPL INTENSE PULSE LIGHT 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 2006-03-16 under 510(k) number K060216. 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 ULTRA VPL INTENSE PULSE LIGHT SYSTEM?

ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-03-16. The listed applicant is Energist, Ltd.. The 510(k) number is K060216.

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

ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM received FDA 510(k) clearance on 2006-03-16, under 510(k) number K060216.

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

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

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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 SYSTEMK082825ENERGIST ULTRAPLUS VARIABLE PULSED LIGHT (VPL) SYSTEM

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Official Source

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