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FDA 510(k)

MolecuLight i:X

K-Number: K191371 · 2019-12-04

ApplicantMolecuLight, Inc.
Decision Date2019-12-04
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 2019-12-04 under approval number K191371. 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 2019-12-04. It is manufactured by MolecuLight, Inc.. The 510(k) number is K191371.

When was MolecuLight i:X approved by the FDA?

MolecuLight i:X received FDA 510(k) clearance on 2019-12-04, under approval number K191371.

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 K211901MolecuLightDX K210882MolecuLight I:X K213840MolecuLight I:X

Related Devices (Code: QJF)

K211901MolecuLightDXMolecuLight, Inc. K210882MolecuLight I:XMolecuLight, Inc. K213840MolecuLight 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.

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