MolecuLightDX®+ Essential System

Primary DI
00628110259639
Brand
MolecuLightDX®+ Essential System
Company
MolecuLight Inc
Model
3155
Published
2026-09-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
false

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
00628110259639PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00628110259639006281102596396281102596390628110259639

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.

Regulatory Flags#

DUNS number
202822052
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628110259530MolecuLightDX®+ Enterprise System26352026-07-08
00628110259448MolecuLightDX Sterile Surgical Sleeve Convenience Kit of 2520962026-07-08
00628110259547Thermal Imaging Module26402026-07-08
00628110259554MolecuLightDX Eco DarkDrapes (Case of 50)25172026-07-08
00628110259578MolecuLightDX DarkDrape Eco Clip23932026-07-08
00628110259585MolecuLightDX+ Thermal Eco Clip23952026-07-08
00628110259295MolecuLight DarkDrape14262022-01-05
00628110259363i:X Sterile Surgical Sleeve Convenience Kit18592022-01-05
00628110259394MolecuLightDX DarkDrape19732022-01-05
00628110259325MolecuLight i:X System1153-112022-01-04
00628110259387MolecuLightDX System20942022-01-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00628110259530MolecuLightDX®+ Enterprise SystemMolecuLight IncQJF2026-07-08
B376KB1000SnapshotGLOKent Imaging IncQJF2025-07-10
00627987231151Ray 1Swift Medical IncQJF2022-04-18
00628110259325MolecuLight i:X SystemMolecuLight IncQJF2022-01-04
00628110259387MolecuLightDX SystemMolecuLight IncQJF2022-01-04