MolecuLight I:X
MolecuLight, Inc.
MOLECULIGHT INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3014704068 | 3014704068 | MOLECULIGHT INC. | 1 | N | 2026-01-01 | 425 UNIVERSITY AVE TORONTO Ontario CA M5G1T6 |
| 3016163973 | 3016163973 | MOLECULIGHT CORP | 1 | Y | 2026-01-01 | 2403 Sidney St Ste 286 Pittsburgh PA US 15203 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 224058 | 2046572023 | K213840 | MolecuLight I:X | QJF | 2022-05-18 |
| 224058 | 1089713233 | K211901 | MolecuLightDX | QJF | 2021-07-21 |
| 224058 | 1477016168 | K191371 | MolecuLight i:X | QJF | 2019-12-04 |
| 224058 | 1350702671 | ||||
| 224058 | 1522880096 | ||||
| 224058 | 1867668480 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| QJF | 3 | 2022-05-18 |
PMN#
MolecuLightDX
MolecuLight Inc.
MolecuLight I:X
MolecuLight, Inc.
MolecuLight I:X
MolecuLight Inc.
GUDID#
MolecuLightDX Sterile Surgical Sleeve Convenience Kit of 25 - Disposable sterile protective cover to enable the MolecuLightDX and MolecuLightDX+ to be used in sterile environments
2026-07-08
MolecuLightDX+ System - 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.
2026-07-08
Thermal Imaging Module - Adds thermal imaging capabilities to the MolecuLightDX+ device to quantify skin temperature changes at the point-of-care.
2026-07-08
MolecuLightDX Eco DarkDrapes (Case of 50) - Drapes that are individually packaged for one-time use to create an optimal lighting environment for imaging wounds while using the MolecuLightDX and MolecuLightDX+
2026-07-08
MolecuLightDX DarkDrape Eco Clip - Reusable clip to attach the DarkDrape to the MolecuLightDX and MolecuLightDX+ device
2026-07-08
MolecuLightDX+ Thermal Eco Clip - For use when the Thermal Imaging Module is attached. (Required with 2517 MolecuLightDX Eco DarkDrapes)
2026-07-08
MolecuLight DarkDrape - Drapes that are individually packaged for one-time use to create an optimal lighting environment for imaging wounds while using the MolecuLight i:X.
2022-01-05
i:X Sterile Surgical Sleeve Convenience Kit - Sterile protective cover for the MolecuLight i:X to be used in a surgical environment.
2022-01-05
MolecuLightDX DarkDrape - Drapes individually packaged for one-time use to create an optimal lighting environment for imaging wounds using the MolecuLightDX.
2022-01-05
MolecuLight i:X System - 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.
2022-01-04
MolecuLightDX System - 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.
2022-01-04