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FDA 510(k)

Grivamax Family of Lasers, Models 272 and 148

K-Number: K211192 · 2021-07-20

ApplicantLeana Orders, Inc.
Decision Date2021-07-20
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Grivamax Family of Lasers, Models 272 and 148 is a medical device manufactured by Leana Orders, Inc.. It received FDA 510(k) clearance on 2021-07-20 under approval number K211192. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Grivamax Family of Lasers, Models 272 and 148?

Grivamax Family of Lasers, Models 272 and 148 is a medical device that received FDA 510(k) clearance on 2021-07-20. It is manufactured by Leana Orders, Inc.. The 510(k) number is K211192.

When was Grivamax Family of Lasers, Models 272 and 148 approved by the FDA?

Grivamax Family of Lasers, Models 272 and 148 received FDA 510(k) clearance on 2021-07-20, under approval number K211192.

What company makes Grivamax Family of Lasers, Models 272 and 148?

Grivamax Family of Lasers, Models 272 and 148 is manufactured by Leana Orders, Inc..

What is the FDA product code for Grivamax Family of Lasers, Models 272 and 148?

The FDA product code for Grivamax Family of Lasers, Models 272 and 148 is OAP.

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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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