Anesthesiology
Review Panel
- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart C—Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- LLOLaser, Neodymium:Yag, Pulmonary Surgery2Product Code
- K884815SLT CLMD CONTACT LASER2Cleared 510(K)
- K881499SURGILASE YAG 100 FOR GYNECOLOGY USE2Cleared 510(K)
- K880592LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE2Cleared 510(K)
- K880170MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS2Cleared 510(K)
- K874254ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS2Cleared 510(K)
- K875104SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE2Cleared 510(K)
- K871876MODEL 5050 SURGILASER FOR PULMONARY USE2Cleared 510(K)
- K872351FIBERLASE II ND:YAG LASER FOR PULMONARY USE2Cleared 510(K)
- K870505OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL2Cleared 510(K)
- K871511SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS2Cleared 510(K)
Show All 19 Submissions
- NQVCatheter, Suction, Tracheobronchial, Reprocessed1Product Code
- QECForceps, Biopsy, Electric Surgical Hemostasis Within Tracheobronchial Tree2Product Code
- OMTAbsorbable Lung Biopsy Plug2Product Code
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Subpart G—MiscellaneousCFR Sub-Part
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OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K870505
- 510(k) Type
- Traditional
- Applicant
- TRIMEDYNE, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 8/7/1987
- Days to Decision
- 184 days