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510(k) K213840

MolecuLight I:X by Moleculight, Inc. — Product Code QJF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2022
Date Received
December 9, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Autofluorescence Imaging Adjunct Tool For Wounds
Device Class
Class II
Regulation Number
878.4550
Review Panel
SU
Submission Type

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.

Other clearances by Moleculight, Inc.

  • K211901 — MolecuLightDX (July 21, 2021)
  • K210882 — MolecuLight I:X (June 22, 2021)
  • K191371 — MolecuLight i:X (December 4, 2019)
  • DEN180008 — MolecuLight i:X (July 31, 2018)

Other clearances for product code QJF

  • K251678 — Swift Ray 1 (February 24, 2026)
  • K242669 — SnapshotGLO (KB100) (March 26, 2025)
  • K230734 — Multispectral Imager Kit (MSI Kit) (300-00015), Multispectral Imager (MSI) (300- (December 5, 2023)
  • K211901 — MolecuLightDX (July 21, 2021)
  • K210882 — MolecuLight I:X (June 22, 2021)
  • K191371 — MolecuLight i:X (December 4, 2019)