MolecuLightDX System

Primary DI
00628110259387
Brand
MolecuLightDX System
Company
MolecuLight Inc
Model
2094
Device description
The MolecuLightDX is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to:(i) View and digitally record images of a wound, (ii) Measure and digitally record the size of a wound, and (iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >10^4 CFU per grams as compared to examination of clinical signs and symptoms alone. The MolecuLightDX device should not be used to rule-out the presence of bacteria in a wound.
Published
2022-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
QJFAutofluorescence Imaging Adjunct Tool For Wounds

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJFAutofluorescence Imaging Adjunct Tool For WoundsGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211901000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211901000MolecuLightDXMolecuLight, Inc.2021-07-21QJF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628110259387PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628110259387006281102593876281102593870628110259387

GMDN Terms#

Term, Definition table
TermDefinition
Fluorescence wound imaging unitA hand-held, electrically-powered device designed to use violet light illumination and imaging to visualize fluorescent bacteria within/around a wound to assist with wound care protocols and documentation. It includes a violet light(s) for wound illumination and fluorescence, lens, display screen, and includes video/image capture technology.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
202822052
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628110259295MolecuLight DarkDrape14262022-01-05
00628110259363i:X Sterile Surgical Sleeve Convenience Kit18592022-01-05
00628110259394MolecuLightDX DarkDrape19732022-01-05
00628110259325MolecuLight i:X System1153-112022-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B376KB1000SnapshotGLOKent Imaging IncQJF2025-07-10
00628110259325MolecuLight i:X SystemMolecuLight IncQJF2022-01-04