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FDA 510(k)

ULTRALIGHT II ND:YAG LASER SYSTEM

K-Number: K041011 · 2004-12-14

ApplicantSandstone Medical Technologies, LLC
Decision Date2004-12-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ULTRALIGHT II ND:YAG LASER SYSTEM 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 2004-12-14 under 510(k) number K041011. 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 ULTRALIGHT II ND:YAG LASER SYSTEM?

ULTRALIGHT II ND:YAG LASER SYSTEM is a medical device that received FDA 510(k) clearance on 2004-12-14. The listed applicant is Sandstone Medical Technologies, LLC. The 510(k) number is K041011.

When did ULTRALIGHT II ND:YAG LASER SYSTEM receive FDA 510(k) clearance?

ULTRALIGHT II ND:YAG LASER SYSTEM received FDA 510(k) clearance on 2004-12-14, under 510(k) number K041011.

Who is the listed applicant for ULTRALIGHT II ND:YAG LASER SYSTEM?

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 ULTRALIGHT II ND:YAG LASER SYSTEM?

The FDA product code for ULTRALIGHT II ND:YAG LASER SYSTEM 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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