FDA 510(k)

LIGHTSCALPEL LS-4020

Numéro K : K213669 · 2023-02-15

Date de décision2023-02-15

Code produitGEX

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

LIGHTSCALPEL LS-4020 is the device name listed in this FDA 510(k) record. The listed applicant is Lightscalpel, Inc.. It received FDA 510(k) clearance on 2023-02-15 under 510(k) 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.

Questions fréquentes

What is the LIGHTSCALPEL LS-4020?

LIGHTSCALPEL LS-4020 is a medical device that received FDA 510(k) clearance on 2023-02-15. The listed applicant is Lightscalpel, Inc.. The 510(k) number is K213669.

When did LIGHTSCALPEL LS-4020 receive FDA 510(k) clearance?

LIGHTSCALPEL LS-4020 received FDA 510(k) clearance on 2023-02-15, under 510(k) number K213669.

Who is the listed applicant for LIGHTSCALPEL LS-4020?

The FDA 510(k) record lists Lightscalpel, Inc. as the applicant. This does not by itself establish the device manufacturer.

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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Source officielle

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