FDA 510(k)

BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100

K-Number: K030959 · 2003-04-25

Decision Date2003-04-25

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 is the device name listed in this FDA 510(k) record. The listed applicant is Laser Peripherals, LLC. It received FDA 510(k) clearance on 2003-04-25 under 510(k) number K030959. 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 BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100?

BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 is a medical device that received FDA 510(k) clearance on 2003-04-25. The listed applicant is Laser Peripherals, LLC. The 510(k) number is K030959.

When did BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 receive FDA 510(k) clearance?

BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 received FDA 510(k) clearance on 2003-04-25, under 510(k) number K030959.

Who is the listed applicant for BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100?

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

What is the FDA product code for BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100?

The FDA product code for BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 is GEX. This falls under the Gastroenterology category.

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Other records listing Laser Peripherals, 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.