MolecuLight i:X System

Primary DI
00628110259325
Brand
MolecuLight i:X System
Company
MolecuLight Inc
Model
1153-11
Device description
The MolecuLight i:X 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 MolecuLight i:X 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
FXNTape, Camera, Surgical
QJFAutofluorescence Imaging Adjunct Tool For Wounds

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXNTape, Camera, SurgicalGeneral, Plastic Surgery1
QJFAutofluorescence Imaging Adjunct Tool For WoundsGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191371000
K210882000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191371000MolecuLight i:XMolecuLight, Inc.2019-12-04QJF
K210882000MolecuLight I:XMolecuLight, Inc.2021-06-22QJF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00628110259325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628110259325006281102593256281102593250628110259325

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
00628110259387MolecuLightDX System20942022-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B376KB1000SnapshotGLOKent Imaging IncQJF2025-07-10
B376KB1000SnapshotGLOKent Imaging IncFXN2025-07-10
00860475000383Automated Wound MeasurementsEPIC SYSTEMS CORPORATIONFXN2025-02-03
09420071400010SilhouetteStarARANZ MEDICAL LIMITEDFXN2024-04-03
17290017272716Minuteful for WoundHEALTHY.IO LTDFXN2024-03-01
17290017272877Minuteful for Wound at HomeHEALTHY.IO LTDFXN2024-03-01
00860003459850eKare inSightE-Kare Inc.FXN2022-12-01
17290017272709Minuteful for WoundHEALTHY.IO LTDFXN2022-09-15
17290017272556SPOTHEALTHY.IO LTDFXN2022-01-17
07290017272504SPOTHEALTHY.IO LTDFXN2022-01-17
00628110259387MolecuLightDX SystemMolecuLight IncQJF2022-01-04
00627987231144Swift VisionSwift Medical IncFXN2021-03-15
17290017272501SPOTHEALTHY.IO LTDFXN2020-08-25
00627987231090Swift Skin and Wound Swift Medical IncFXN2019-10-04
00627987231106PointClickCare Skin and WoundSwift Medical IncFXN2019-10-04
00627987231113Healogics Photo+Swift Medical IncFXN2019-10-04
00627987231137Medline NE1® WMSSwift Medical IncFXN2019-10-04
00850677007143PACS Scan MobileHYLAND LLCFXN2019-08-30
06953825902605Dr.meter®Shenzhen Urion Technology Co., LtdFXN2017-03-29