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FDA 510(k)

LS-40 CO2 LASER SYSTEM MODEL LS-40

K-Number: K093793 · 2010-02-18

ApplicantSandstone Medical Technologies, LLC
Decision Date2010-02-18
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LS-40 CO2 LASER SYSTEM MODEL LS-40 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 2010-02-18 under 510(k) number K093793. 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-40 CO2 LASER SYSTEM MODEL LS-40?

LS-40 CO2 LASER SYSTEM MODEL LS-40 is a medical device that received FDA 510(k) clearance on 2010-02-18. The listed applicant is Sandstone Medical Technologies, LLC. The 510(k) number is K093793.

When did LS-40 CO2 LASER SYSTEM MODEL LS-40 receive FDA 510(k) clearance?

LS-40 CO2 LASER SYSTEM MODEL LS-40 received FDA 510(k) clearance on 2010-02-18, under 510(k) number K093793.

Who is the listed applicant for LS-40 CO2 LASER SYSTEM MODEL LS-40?

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-40 CO2 LASER SYSTEM MODEL LS-40?

The FDA product code for LS-40 CO2 LASER SYSTEM MODEL LS-40 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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