FDA Browser
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Innolitics
Anesthesiology
Review Panel
Cardiovascular
Review Panel
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Review Panel
Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
General Hospital
Review Panel
Hematology
Review Panel
Immunology
Review Panel
Microbiology
Review Panel
Neurology
Review Panel
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Review Panel
Ophthalmic
Review Panel
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Review Panel
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Review Panel
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Review Panel
Radiology
Review Panel
General and Plastic Surgery
Review Panel
Miscellaneous
Miscellaneous
Subpart B—Diagnostic Devices
CFR Sub-Part
GCI
Laryngoscope, Endoscope
2
Product Code
GCJ
Laparoscope, General & Plastic Surgery
2
Product Code
MFJ
Device, Endoscopic Suturing
2
Product Code
EPY
Speculum, Ent
1
Product Code
NAY
System, Surgical, Computer Controlled Instrument
2
Product Code
NEQ
Device, Telemedicine, Robotic
2
Product Code
PDT
Burn Resuscitation Decision Support Software
2
Product Code
FDP
Apparatus, Pneumoperitoneum, Automatic
2
Product Code
GCG
Peritoneoscope
2
Product Code
GCH
Mediastinoscope, Diagnostic
2
Product Code
OTJ
Laparoscopic Single Port Access Device
2
Product Code
OWN
Confocal Optical Imaging
2
Product Code
K
23
3333
KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
2
Cleared 510(K)
K
23
2857
KARL STORZ ICG Imaging System
2
Cleared 510(K)
K
23
1854
1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
2
Cleared 510(K)
K
23
1344
ActivSight Intraoperative Imaging System
2
Cleared 510(K)
K
23
0407
FloNavi Open Field Fluorescence Imaging System
2
Cleared 510(K)
K
23
0754
L12 LED Light Source with AIM
2
Cleared 510(K)
K
21
3943
SmartSurgN Visualization System
2
Cleared 510(K)
K
22
3020
VS3-Iridium System (VS3-IR)
2
Cleared 510(K)
K
22
1611
780 nm L11 LED Light Source with AIM
2
Cleared 510(K)
K
22
0477
Cellvizio 100 series system with confocal Miniprobes
2
Cleared 510(K)
Show All 52 Submissions
QGY
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
2
Product Code
NQQ
System, Imaging, Optical Coherence Tomography (Oct)
2
Product Code
POY
Post Breast Biopsy Hemostatic Breast Compression Device
2
Product Code
FXE
Speculum, Non-Illuminated
1
Product Code
FXF
Speculum, Illuminated
1
Product Code
FXG
Specula Accessories
1
Product Code
JYK
Holder, Ear Speculum
1
Product Code
KAG
Holder, Speculum, Ent
1
Product Code
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
2
Product Code
QZB
Software Controlled Endoscope And Instrument Holder
2
Product Code
Subpart C—General Hospital and Personal Use Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Neurological Surgical Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
Subpart F—General Hospital and Personal Use Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
SU
/
subpart-b—diagnostic-devices
/
OWN
/
K230754
View Source
L12 LED Light Source with AIM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Miscellaneous
Subpart B—Diagnostic Devices
GCI
Laryngoscope, Endoscope
GCJ
Laparoscope, General & Plastic Surgery
MFJ
Device, Endoscopic Suturing
EPY
Speculum, Ent
NAY
System, Surgical, Computer Controlled Instrument
NEQ
Device, Telemedicine, Robotic
PDT
Burn Resuscitation Decision Support Software
FDP
Apparatus, Pneumoperitoneum, Automatic
GCG
Peritoneoscope
GCH
Mediastinoscope, Diagnostic
OTJ
Laparoscopic Single Port Access Device
OWN
Confocal Optical Imaging
K
23
3333
KARL STORZ ICG Imaging System, KARL STORZ Image1S Camera Control Unit
K
23
2857
KARL STORZ ICG Imaging System
K
23
1854
1788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIM
K
23
1344
ActivSight Intraoperative Imaging System
K
23
0407
FloNavi Open Field Fluorescence Imaging System
K
23
0754
L12 LED Light Source with AIM
K
21
3943
SmartSurgN Visualization System
K
22
3020
VS3-Iridium System (VS3-IR)
K
22
1611
780 nm L11 LED Light Source with AIM
K
22
0477
Cellvizio 100 series system with confocal Miniprobes
Show All 52 Submissions
QGY
Mobile / Tablet Software Application To Control Settings Of Surgical And Endoscopic Camera
NQQ
System, Imaging, Optical Coherence Tomography (Oct)
POY
Post Breast Biopsy Hemostatic Breast Compression Device
FXE
Speculum, Non-Illuminated
FXF
Speculum, Illuminated
FXG
Specula Accessories
JYK
Holder, Ear Speculum
KAG
Holder, Speculum, Ent
QSM
System, Surgical, Computer Controlled Instrument, Remanufactured
QZB
Software Controlled Endoscope And Instrument Holder
Subpart C—General Hospital and Personal Use Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Neurological Surgical Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Toxicology
Medical Genetics
Unknown
SU
/
subpart-b—diagnostic-devices
/
OWN
/
K230754
View Source
L12 LED Light Source with AIM
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Loading...