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FDA 510(k)

LIGHTLANCE LASER SKIN PERFORATOR

K-Number: K013021 · 2002-05-30

ApplicantInnotech USA, Inc.
Decision Date2002-05-30
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHTLANCE LASER SKIN PERFORATOR is the device name listed in this FDA 510(k) record. The listed applicant is Innotech USA, Inc.. It received FDA 510(k) clearance on 2002-05-30 under 510(k) number K013021. 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 LIGHTLANCE LASER SKIN PERFORATOR?

LIGHTLANCE LASER SKIN PERFORATOR is a medical device that received FDA 510(k) clearance on 2002-05-30. The listed applicant is Innotech USA, Inc.. The 510(k) number is K013021.

When did LIGHTLANCE LASER SKIN PERFORATOR receive FDA 510(k) clearance?

LIGHTLANCE LASER SKIN PERFORATOR received FDA 510(k) clearance on 2002-05-30, under 510(k) number K013021.

Who is the listed applicant for LIGHTLANCE LASER SKIN PERFORATOR?

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

What is the FDA product code for LIGHTLANCE LASER SKIN PERFORATOR?

The FDA product code for LIGHTLANCE LASER SKIN PERFORATOR is GEX. This falls under the Gastroenterology category.

Related Clinical Trials

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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Other records listing Innotech USA, Inc. 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.

K033251THE FRIENDLYLIGHT ND: YAG LASERSK000023FRIENDLY LIGHT ER:YAG PULSED LASER

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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