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FDA 510(k)

LVI AESTHETIC LASER

K-Number: K041721 · 2004-08-05

ApplicantHoya Photonics, Inc.
Decision Date2004-08-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LVI AESTHETIC LASER is the device name listed in this FDA 510(k) record. The listed applicant is Hoya Photonics, Inc.. It received FDA 510(k) clearance on 2004-08-05 under 510(k) number K041721. 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 LVI AESTHETIC LASER?

LVI AESTHETIC LASER is a medical device that received FDA 510(k) clearance on 2004-08-05. The listed applicant is Hoya Photonics, Inc.. The 510(k) number is K041721.

When did LVI AESTHETIC LASER receive FDA 510(k) clearance?

LVI AESTHETIC LASER received FDA 510(k) clearance on 2004-08-05, under 510(k) number K041721.

Who is the listed applicant for LVI AESTHETIC LASER?

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

What is the FDA product code for LVI AESTHETIC LASER?

The FDA product code for LVI AESTHETIC LASER is GEX. This falls under the Gastroenterology category.

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Other records listing Hoya Photonics, Inc. as applicant

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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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