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510(k) K213840

Device
MolecuLight I:X
Applicant
MolecuLight, Inc.
510(k) number
K213840
Product code
QDG  
Decision
Substantially Equivalent (SESE)
Decision date
2022-05-18
Date received
2021-12-09
Regulation
878.4550
Classification name
Parathyroid Autofluorescence Imaging Device
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
Jordan John
Address
Suite 700, 425 University Ave. Toronto CA M5G 1T6 M5G 1T6

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QDG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253303Dendrite Imaging SystemDendrite Imaging, Inc.2025-11-28
K250455FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)Fluoptics Sas (A Getinge Group Company}2025-04-17
K233564FLUOBEAM® LX Imaging System (FB-LX); FLUOBEAM® LX Red Imaging System (FB-LXR)Fluoptics Sas (A Getinge Group Company)2023-12-15
K230898FLUOBEAM® LX RedFluoptics Sas2023-07-28
K190891Fluobeam LXFluoptics2019-07-31
DEN170092Fluobeam 800 Clinic Imaging Device used with Fluocase 800 Control SystemFluoptics2018-11-02

Legacy Summary#

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FDA Review#

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