FDA 510(k)

LightScalpel

K-Number: K173827 · 2018-09-14

Decision Date2018-09-14

Product CodeGEX

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

LightScalpel is a medical device manufactured by Lightscalpel, LLC. It received FDA 510(k) clearance on 2018-09-14 under approval number K173827. 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 LightScalpel?

LightScalpel is a medical device that received FDA 510(k) clearance on 2018-09-14. It is manufactured by Lightscalpel, LLC. The 510(k) number is K173827.

When was LightScalpel approved by the FDA?

LightScalpel received FDA 510(k) clearance on 2018-09-14, under approval number K173827.

What company makes LightScalpel?

LightScalpel is manufactured by Lightscalpel, LLC.

What is the FDA product code for LightScalpel?

The FDA product code for LightScalpel is GEX. This falls under the Gastroenterology category.

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Official Source

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