FDA Registration
Active
🇨🇦 Canada
MOLECULIGHT INC.
Reg #: 3014704068
·
FEI: 3014704068
·
Expires 2026
Products
4
Proprietary Names
12
Establishment Types
3
Classifications
4
Registration Details
- Registration Name
- MOLECULIGHT INC.
- Registration Number
- 3014704068
- FEI Number
- 3014704068
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 425 UNIVERSITY AVE
- City
- TORONTO Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K213840
Owner / Operator
- Firm Name
- MolecuLight Inc.
- Operator Number
- 10058911
- Address
- 425 UNIVERSITY AVE
- City
- TORONTO
- State
- Ontario
- Postal Code
- M5G1T6
- Country
- CA
- Correspondent
- Jordan John
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| General Surgery Tray | LRO | Class 2 | General, Plastic Surgery | No | 2020-07-08 |
| Autofluorescence Imaging Adjunct Tool For Wounds | QJF | Class 2 | General, Plastic Surgery | No | 2024-03-01 |
| Tape, Camera, Surgical | FXN | Class 1 | General, Plastic Surgery | No | 2024-03-01 |
| Drape, Surgical, Exempt | PUI | Class 2 | General, Plastic Surgery | No | 2019-01-11 |
Proprietary Names
i:X Sterile Surgical Sleeve Convenience Kit
MolecuLightDX Sterile Sleeve
Thermal Imaging Module
MolecuLight i:X
MolecuLightDX DarkDrape
MolecuLight DarkDrape
MolecuLightDX+ Thermal Eco Clip
MolecuLightDX DarkDrape Eco
MolecuLightDX DarkDrape Eco Clip
MolecuLightDX
MolecuLightDX+ System
MolecuLightDX+
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device