Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Grivamax Family of Lasers, Models 272 and 148

K-Number: K211192 · 2021-07-20

Decision Date2021-07-20
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Grivamax Family of Lasers, Models 272 and 148 is the device name listed in this FDA 510(k) record. The listed applicant is Leana Orders, Inc.. It received FDA 510(k) clearance on 2021-07-20 under 510(k) 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. The listed applicant is Leana Orders, Inc.. The 510(k) number is K211192.

When did Grivamax Family of Lasers, Models 272 and 148 receive FDA 510(k) clearance?

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

Who is the listed applicant for Grivamax Family of Lasers, Models 272 and 148?

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

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.

Other records listing Leana Orders, Inc. as applicant

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.

Related Devices (Code: OAP)

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.