FDA 510(k)

LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT)

K-Number: K040563 · 2004-10-08

ApplicantSandstone Medical Technologies, LLC

Decision Date2004-10-08

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) is the device name listed in this FDA 510(k) record. The listed applicant is Sandstone Medical Technologies, LLC. It received FDA 510(k) clearance on 2004-10-08 under 510(k) number K040563. 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 LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT)?

LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) is a medical device that received FDA 510(k) clearance on 2004-10-08. The listed applicant is Sandstone Medical Technologies, LLC. The 510(k) number is K040563.

When did LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) receive FDA 510(k) clearance?

LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) received FDA 510(k) clearance on 2004-10-08, under 510(k) number K040563.

Who is the listed applicant for LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT)?

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

What is the FDA product code for LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT)?

The FDA product code for LS FAMILY OF CO2 LASERS INCLUDING: LS-15 LASER SYSTEM (15 WATT) AND LS-25 LASER SYSTEM (25 WATT) is GEX. This falls under the Gastroenterology category.

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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.