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FDA 510(k)

MolecuLightDX

K-Number: K211901 · 2021-07-21

ApplicantMolecuLight, Inc.
Decision Date2021-07-21
Product CodeQJF
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MolecuLightDX is a medical device manufactured by MolecuLight, Inc.. It received FDA 510(k) clearance on 2021-07-21 under approval number K211901. 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 MolecuLightDX?

MolecuLightDX is a medical device that received FDA 510(k) clearance on 2021-07-21. It is manufactured by MolecuLight, Inc.. The 510(k) number is K211901.

When was MolecuLightDX approved by the FDA?

MolecuLightDX received FDA 510(k) clearance on 2021-07-21, under approval number K211901.

What company makes MolecuLightDX?

MolecuLightDX is manufactured by MolecuLight, Inc..

What is the FDA product code for MolecuLightDX?

The FDA product code for MolecuLightDX is QJF.

Other Devices by MolecuLight, Inc.

DEN180008MolecuLight i:X K191371MolecuLight i:X K210882MolecuLight I:X K213840MolecuLight I:X

Related Devices (Code: QJF)

K191371MolecuLight i:XMolecuLight, 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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