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FDA 510(k)

CarnaLife Holo

K-Number: K221870 · 2023-05-01

ApplicantMedapp S.A.
Decision Date2023-05-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CarnaLife Holo is a medical device manufactured by Medapp S.A.. It received FDA 510(k) clearance on 2023-05-01 under approval number K221870. 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 CarnaLife Holo?

CarnaLife Holo is a medical device that received FDA 510(k) clearance on 2023-05-01. It is manufactured by Medapp S.A.. The 510(k) number is K221870.

When was CarnaLife Holo approved by the FDA?

CarnaLife Holo received FDA 510(k) clearance on 2023-05-01, under approval number K221870.

What company makes CarnaLife Holo?

CarnaLife Holo is manufactured by Medapp S.A..

What is the FDA product code for CarnaLife Holo?

The FDA product code for CarnaLife Holo is LLZ.

Related PubMed Literature

PMID: 40346298 An attempt to evaluate the use of mixed reality in surgically treated pediatric oncology patients. NPJ digital medicine (2025)

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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.

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