MolecuLightDX System

GUDID 00628110259387

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.

MolecuLight Inc

Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit Fluorescence wound imaging unit

• Primary Device ID: 00628110259387
• NIH Device Record Key: a6cc2ba9-4155-4034-83df-15848d4d6d69
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MolecuLightDX System
• Version Model Number: 2094
• Company DUNS: 202822052
• Company Name: MolecuLight Inc
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00628110259387 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211901

FDA Product Code

• QJF: Autofluorescence Imaging Adjunct Tool For Wounds

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-01-12
• Device Publish Date: 2022-01-04

Devices Manufactured by MolecuLight Inc

• 00628110259325 - MolecuLight i:X System: 2022-01-12 The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care,
• 00628110259387 - MolecuLightDX System: 2022-01-12The 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.
• 00628110259387 - MolecuLightDX System: 2022-01-12 The MolecuLightDX is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, t