LIGHTSCALPEL LS-4020
K-Number: K213669 · 2023-02-15
ApplicantLightscalpel, Inc.
Decision Date2023-02-15
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
LIGHTSCALPEL LS-4020 is a medical device manufactured by Lightscalpel, Inc.. It received FDA 510(k) clearance on 2023-02-15 under approval number K213669. 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 LS-4020?
LIGHTSCALPEL LS-4020 is a medical device that received FDA 510(k) clearance on 2023-02-15. It is manufactured by Lightscalpel, Inc.. The 510(k) number is K213669.
When was LIGHTSCALPEL LS-4020 approved by the FDA?
LIGHTSCALPEL LS-4020 received FDA 510(k) clearance on 2023-02-15, under approval number K213669.
What company makes LIGHTSCALPEL LS-4020?
LIGHTSCALPEL LS-4020 is manufactured by Lightscalpel, Inc..
What is the FDA product code for LIGHTSCALPEL LS-4020?
The FDA product code for LIGHTSCALPEL LS-4020 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.