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FDA 510(k)

LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE

K-Number: K082101 · 2008-11-05

ApplicantSandstone Medical Technologies, LLC
Decision Date2008-11-05
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE 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 2008-11-05 under 510(k) number K082101. 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 WITH SCANNING HANDPIECE?

LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE is a medical device that received FDA 510(k) clearance on 2008-11-05. The listed applicant is Sandstone Medical Technologies, LLC. The 510(k) number is K082101.

When did LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE receive FDA 510(k) clearance?

LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE received FDA 510(k) clearance on 2008-11-05, under 510(k) number K082101.

Who is the listed applicant for LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE?

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 WITH SCANNING HANDPIECE?

The FDA product code for LS FAMILY OF CO2 LASERS WITH SCANNING HANDPIECE 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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