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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 the device name listed in this FDA 510(k) record. The listed applicant is MolecuLight, Inc.. It received FDA 510(k) clearance on 2019-12-04 under 510(k) 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. The listed applicant is MolecuLight, Inc.. The 510(k) number is K191371.

When did MolecuLight i:X receive FDA 510(k) clearance?

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

Who is the listed applicant for MolecuLight i:X?

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

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

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

Related Clinical Trials

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.

NCT04207099Comparing Wound Area Reduction of Non-healing DFUs Using MolecuLight i:X Versus Standard of CareCOMPLETEDNCT05196880Biofilm Correlation and ValidationCOMPLETEDNCT06682923MolecuLightDX Measurement Feature Clinical ValidationCOMPLETEDNCT07646938MolecuLight All-in-One Oxygenation Clinical UtilityCOMPLETED

Other records listing MolecuLight, 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.

K213840MolecuLight I:XK211901MolecuLightDXK210882MolecuLight I:X

Related Devices (Code: QJF)

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.

K251678Swift Ray 1Swift Medical, Inc.K242669SnapshotGLO (KB100)Kent Imaging, Inc.K230734Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)Precision Healing, LLCK213840MolecuLight I:XMolecuLight, Inc.K211901MolecuLightDXMolecuLight, Inc.K210882MolecuLight I:XMolecuLight, 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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