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Innolitics
Anesthesiology
Review Panel
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Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
CFR Sub-Part
Subpart B—Diagnostic Devices
CFR Sub-Part
Subpart C—Cardiovascular Monitoring Devices
CFR Sub-Part
Subpart C—Monitoring Devices
CFR Sub-Part
Subpart D—Prosthetic Devices
CFR Sub-Part
Subpart E—Surgical Devices
CFR Sub-Part
LLO
Laser, Neodymium:Yag, Pulmonary Surgery
2
Product Code
K
88
4815
SLT CLMD CONTACT LASER
2
Cleared 510(K)
K
88
1499
SURGILASE YAG 100 FOR GYNECOLOGY USE
2
Cleared 510(K)
K
88
0592
LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE
2
Cleared 510(K)
K
88
0170
MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
2
Cleared 510(K)
K
87
4254
ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS
2
Cleared 510(K)
K
87
5104
SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE
2
Cleared 510(K)
K
87
1876
MODEL 5050 SURGILASER FOR PULMONARY USE
2
Cleared 510(K)
K
87
2351
FIBERLASE II ND:YAG LASER FOR PULMONARY USE
2
Cleared 510(K)
K
87
0505
OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL
2
Cleared 510(K)
K
87
1511
SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
2
Cleared 510(K)
Show All 19 Submissions
NQV
Catheter, Suction, Tracheobronchial, Reprocessed
1
Product Code
QEC
Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
2
Product Code
OMT
Absorbable Lung Biopsy Plug
2
Product Code
Subpart F—Cardiovascular Therapeutic Devices
CFR Sub-Part
Subpart F—Neurological Therapeutic Devices
CFR Sub-Part
Subpart F—Physical Medicine Therapeutic Devices
CFR Sub-Part
Subpart F—Therapeutic Devices
CFR Sub-Part
Subpart G—Miscellaneous
CFR Sub-Part
Cardiovascular
Review Panel
Chemistry
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Dental
Review Panel
Ear, Nose, Throat
Review Panel
Gastroenterology and Urology
Review Panel
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Review Panel
Hematology
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Review Panel
Microbiology
Review Panel
Neurology
Review Panel
Obstetrical and Gynecological
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Ophthalmic
Review Panel
Orthopedic
Review Panel
Pathology
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Physical Medicine
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General and Plastic Surgery
Review Panel
Toxicology
Review Panel
Medical Genetics
Review Panel
Unknown
Review Panel
Last synced on 16 August 2024 at 11:05 pm
AN
/
subpart-e—surgical-devices
/
LLO
/
K871511
View Source
SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K871511
510(k) Type
Traditional
Applicant
MEDICAL ENERGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/21/1987
Days to Decision
92 days
FDA Browser
by
Innolitics
Anesthesiology
Miscellaneous
Subpart B—Cardiovascular Diagnostic Devices
Subpart B—Diagnostic Devices
Subpart C—Cardiovascular Monitoring Devices
Subpart C—Monitoring Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
LLO
Laser, Neodymium:Yag, Pulmonary Surgery
K
88
4815
SLT CLMD CONTACT LASER
K
88
1499
SURGILASE YAG 100 FOR GYNECOLOGY USE
K
88
0592
LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE
K
88
0170
MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
K
87
4254
ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS
K
87
5104
SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE
K
87
1876
MODEL 5050 SURGILASER FOR PULMONARY USE
K
87
2351
FIBERLASE II ND:YAG LASER FOR PULMONARY USE
K
87
0505
OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL
K
87
1511
SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
Show All 19 Submissions
NQV
Catheter, Suction, Tracheobronchial, Reprocessed
QEC
Forceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree
OMT
Absorbable Lung Biopsy Plug
Subpart F—Cardiovascular Therapeutic Devices
Subpart F—Neurological Therapeutic Devices
Subpart F—Physical Medicine Therapeutic Devices
Subpart F—Therapeutic Devices
Subpart G—Miscellaneous
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
Toxicology
Medical Genetics
Unknown
AN
/
subpart-e—surgical-devices
/
LLO
/
K871511
View Source
SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS
Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K871511
510(k) Type
Traditional
Applicant
MEDICAL ENERGY, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
7/21/1987
Days to Decision
92 days