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FDA 510(k)

AIP INTENSE PULSED LIGHT SYSTEM

K-Number: K041554 · 2005-04-27

ApplicantAesthera Corporation
Decision Date2005-04-27
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AIP INTENSE PULSED LIGHT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesthera Corporation. It received FDA 510(k) clearance on 2005-04-27 under 510(k) number K041554. 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 AIP INTENSE PULSED LIGHT SYSTEM?

AIP INTENSE PULSED LIGHT SYSTEM is a medical device that received FDA 510(k) clearance on 2005-04-27. The listed applicant is Aesthera Corporation. The 510(k) number is K041554.

When did AIP INTENSE PULSED LIGHT SYSTEM receive FDA 510(k) clearance?

AIP INTENSE PULSED LIGHT SYSTEM received FDA 510(k) clearance on 2005-04-27, under 510(k) number K041554.

Who is the listed applicant for AIP INTENSE PULSED LIGHT SYSTEM?

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

What is the FDA product code for AIP INTENSE PULSED LIGHT SYSTEM?

The FDA product code for AIP INTENSE PULSED LIGHT SYSTEM is GEX. This falls under the Gastroenterology category.

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Other records listing Aesthera Corporation 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.

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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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