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FDA 510(k)

LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM

K-Number: K041419 · 2004-08-26

ApplicantMedical Energy, Inc.
Decision Date2004-08-26
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Energy, Inc.. It received FDA 510(k) clearance on 2004-08-26 under 510(k) number K041419. 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 LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM?

LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2004-08-26. The listed applicant is Medical Energy, Inc.. The 510(k) number is K041419.

When did LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM receive FDA 510(k) clearance?

LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM received FDA 510(k) clearance on 2004-08-26, under 510(k) number K041419.

Who is the listed applicant for LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM?

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

What is the FDA product code for LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM?

The FDA product code for LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM is GEX. This falls under the Gastroenterology category.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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