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FDA 510(k)

PtoleMedic System

K-Number: K202521 · 2021-05-04

ApplicantLento Medical Innovation, Inc.
Decision Date2021-05-04
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PtoleMedic System is a medical device manufactured by Lento Medical Innovation, Inc.. It received FDA 510(k) clearance on 2021-05-04 under approval number K202521. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PtoleMedic System?

PtoleMedic System is a medical device that received FDA 510(k) clearance on 2021-05-04. It is manufactured by Lento Medical Innovation, Inc.. The 510(k) number is K202521.

When was PtoleMedic System approved by the FDA?

PtoleMedic System received FDA 510(k) clearance on 2021-05-04, under approval number K202521.

What company makes PtoleMedic System?

PtoleMedic System is manufactured by Lento Medical Innovation, Inc..

What is the FDA product code for PtoleMedic System?

The FDA product code for PtoleMedic System is LLZ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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