MolecuLight I:X
FDA 510(k) K210882 · MolecuLight, Inc.
510(k) numberK210882
Submission
- Device name
- MolecuLight I:X
- Applicant
- MolecuLight, Inc.
Toronto, CA - Received
- March 25, 2021
- Decision date
- June 22, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QJF – Autofluorescence Imaging Adjunct Tool For Wounds
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4550
- Specialty
- General, Plastic Surgery
An autofluorescence detection device for general surgery and dermatological use is an adjunct tool that uses autofluorescence to detect tissues or structures. This device is not intended to provide a diagnosis.
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251678 | Swift Ray 1QJF · Traditional | Swift Medical, Inc. | 02/24/2026SE |
| K242669 | SnapshotGLO (KB100)QJF · Traditional | Kent Imaging, Inc. | 03/26/2025SE |
| K230734 | Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300-00009)QJF · Traditional | Precision Healing, LLC | 12/05/2023SE |
| K213840 | MolecuLight I:XQJF · Traditional | MolecuLight, Inc. | 05/18/2022SE |
| K211901 | MolecuLightDXQJF · Special | MolecuLight, Inc. | 07/21/2021SE |
| K191371 | MolecuLight i:XQJF · Traditional | MolecuLight, Inc. | 12/04/2019SE |
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Questions and answers
When was MolecuLight I:X cleared by the FDA?
MolecuLight I:X (K210882) received a 510(k) decision of Substantially Equivalent on June 22, 2021, 89 days after the submission was received.
What is the product code of K210882?
The FDA product code is QJF – Autofluorescence Imaging Adjunct Tool For Wounds, a Class II (moderate risk) device regulated under 21 CFR 878.4550.