MolecuLight Inc

Address:425 UNIVERSITY AVE,TORONTO Ontario,CA

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Autofluorescence Imaging Adjunct Tool For Wounds (QJF) (2) Drape, Surgical, Exempt (PUI) (2) Drape, Surgical (KKX) (1) Tape, Camera, Surgical (FXN) (1)

Premarket Exempt

No Yes

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MolecuLight DarkDrape - 00628110259295 Catalog Number :

Device Description : Drapes that are individually packaged for one-time use to create an optimal ligh Drapes that are individually packaged for one-time use to create an optimal lighting environment for imaging wounds while using the MolecuLight i:X.

Device Class : 2

Duns Number: 202822052

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

MolecuLight i:X System - 00628110259325 Catalog Number :

Device Description : The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing 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.

Device Class : 1

Duns Number: 202822052

Premarket Exempt : No

Product Code : QJF, FXN

Prescription Use : Yes

Device Count : 1

i:X Sterile Surgical Sleeve Convenience Kit - 00628110259363 Catalog Number :

Device Description : Sterile protective cover for the MolecuLight i:X to be used in a surgical environment.

Device Class : 2

Duns Number: 202822052

Premarket Exempt : No

Product Code : KKX

Prescription Use : Yes

Device Count : 1

MolecuLightDX System - 00628110259387 Catalog Number :

Device Description : The MolecuLightDX is a handheld imaging tool that allows clinicians diagnosing a 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.

Device Class : 2

Duns Number: 202822052

Premarket Exempt : No

Product Code : QJF

Prescription Use : Yes

Device Count : 1

MolecuLightDX DarkDrape - 00628110259394 Catalog Number :

Device Description : Drapes individually packaged for one-time use to create an optimal lighting envi Drapes individually packaged for one-time use to create an optimal lighting environment for imaging wounds using the MolecuLightDX.

Device Class : 2

Duns Number: 202822052

Premarket Exempt : Yes

Product Code : PUI

Prescription Use : Yes

Device Count : 1

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