Le'Pen
K-Number: K181597 · 2019-04-01
Device Summary
Frequently Asked Questions
What is the Le'Pen?
Le'Pen is a medical device that received FDA 510(k) clearance on 2019-04-01. The listed applicant is Kmihh, Ltd.. The 510(k) number is K181597.
When did Le'Pen receive FDA 510(k) clearance?
Le'Pen received FDA 510(k) clearance on 2019-04-01, under 510(k) number K181597.
Who is the listed applicant for Le'Pen?
The FDA 510(k) record lists Kmihh, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Le'Pen?
The FDA product code for Le'Pen is EBZ.
Related Devices (Code: EBZ)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.