FDA 510(k)

PtoleMedic System

K-Number: K202521 · 2021-05-04

Decision Date2021-05-04

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

PtoleMedic System is the device name listed in this FDA 510(k) record. The listed applicant is Lento Medical Innovation, Inc.. It received FDA 510(k) clearance on 2021-05-04 under 510(k) 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. The listed applicant is Lento Medical Innovation, Inc.. The 510(k) number is K202521.

When did PtoleMedic System receive FDA 510(k) clearance?

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

Who is the listed applicant for PtoleMedic System?

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

What is the FDA product code for PtoleMedic System?

The FDA product code for PtoleMedic System is LLZ.

Related Devices (Code: LLZ)

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.

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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.