510(k) K191371
- Device
- MolecuLight I:X
- Applicant
- MolecuLight Inc.
- 510(k) number
- K191371
- Product code
- QJF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-12-04
- Date received
- 2019-05-22
- Regulation
- 878.4550
- Classification name
- Autofluorescence Imaging Adjunct Tool For Wounds
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Anil Amlani
- Address
- Suite 700, 425 University Ave. Toronto CA M5G 1T6 M5G 1T6
FDA Registration Numbers#
- 3018781093
- 3039395626
- 3014704068
- 3001744314
- 3041244757
- 3009771004
- 3013443304
Source Documents#
Other 510(k) Records For Product Code QJF #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251678 | Swift Ray 1 | Swift Medical, Inc. | 2026-02-24 |
| K242669 | SnapshotGLO (KB100) | Kent Imaging, Inc. | 2025-03-26 |
| K230734 | Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009) | Precision Healing, LLC | 2023-12-05 |
| K213840 | MolecuLight I:X | MolecuLight, Inc. | 2022-05-18 |
| K211901 | MolecuLightDX | MolecuLight, Inc. | 2021-07-21 |
| K210882 | MolecuLight I:X | MolecuLight, Inc. | 2021-06-22 |
Legacy Summary#
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FDA Review#
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