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FDA 510(k)

LORAD LT-100 LASER TREATMENT SYSTEM

K-Number: K992597 · 2000-04-24

ApplicantFocus Medical, LLC
Decision Date2000-04-24
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LORAD LT-100 LASER TREATMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Focus Medical, LLC. It received FDA 510(k) clearance on 2000-04-24 under 510(k) number K992597. 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 LORAD LT-100 LASER TREATMENT SYSTEM?

LORAD LT-100 LASER TREATMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2000-04-24. The listed applicant is Focus Medical, LLC. The 510(k) number is K992597.

When did LORAD LT-100 LASER TREATMENT SYSTEM receive FDA 510(k) clearance?

LORAD LT-100 LASER TREATMENT SYSTEM received FDA 510(k) clearance on 2000-04-24, under 510(k) number K992597.

Who is the listed applicant for LORAD LT-100 LASER TREATMENT SYSTEM?

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

What is the FDA product code for LORAD LT-100 LASER TREATMENT SYSTEM?

The FDA product code for LORAD LT-100 LASER TREATMENT 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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