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

FDA 510(k)

MolecuLight I:X

K-Number: K213840 · 2022-05-18

ApplicantMolecuLight, Inc.
Decision Date2022-05-18
Product CodeQJF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MolecuLight I:X is a medical device manufactured by MolecuLight, Inc.. It received FDA 510(k) clearance on 2022-05-18 under approval number K213840. The device is classified under product code QJF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MolecuLight I:X?

MolecuLight I:X is a medical device that received FDA 510(k) clearance on 2022-05-18. It is manufactured by MolecuLight, Inc.. The 510(k) number is K213840.

When was MolecuLight I:X approved by the FDA?

MolecuLight I:X received FDA 510(k) clearance on 2022-05-18, under approval number K213840.

What company makes MolecuLight I:X?

MolecuLight I:X is manufactured by MolecuLight, Inc..

What is the FDA product code for MolecuLight I:X?

The FDA product code for MolecuLight I:X is QJF.

Other Devices by MolecuLight, Inc.

DEN180008MolecuLight i:X K191371MolecuLight i:X K211901MolecuLightDX K210882MolecuLight I:X

Related Devices (Code: QJF)

K191371MolecuLight i:XMolecuLight, Inc. K211901MolecuLightDXMolecuLight, Inc. K210882MolecuLight I:XMolecuLight, Inc. K230734Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)Precision Healing, LLC K242669SnapshotGLO (KB100)Kent Imaging, Inc. K251678Swift Ray 1Swift Medical, Inc.

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.

↑