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FDA 510(k)

BWF-5 MEDICAL LASER SERIES

K-Number: K123031 · 2012-12-03

ApplicantLitecure, LLC
Decision Date2012-12-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

BWF-5 MEDICAL LASER SERIES is the device name listed in this FDA 510(k) record. The listed applicant is Litecure, LLC. It received FDA 510(k) clearance on 2012-12-03 under 510(k) number K123031. 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 BWF-5 MEDICAL LASER SERIES?

BWF-5 MEDICAL LASER SERIES is a medical device that received FDA 510(k) clearance on 2012-12-03. The listed applicant is Litecure, LLC. The 510(k) number is K123031.

When did BWF-5 MEDICAL LASER SERIES receive FDA 510(k) clearance?

BWF-5 MEDICAL LASER SERIES received FDA 510(k) clearance on 2012-12-03, under 510(k) number K123031.

Who is the listed applicant for BWF-5 MEDICAL LASER SERIES?

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

What is the FDA product code for BWF-5 MEDICAL LASER SERIES?

The FDA product code for BWF-5 MEDICAL LASER SERIES is GEX. This falls under the Gastroenterology category.

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Other records listing Litecure, LLC as applicant

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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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