Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- Diagnostic DevicesCFR Sub-Part
- General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Neurological Surgical DevicesCFR Sub-Part
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- Prosthetic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- NGUBalloon, Liver Tamponade2Product Code
- EYRTourniquet, Gastro-Urology1Product Code
- EXMTruss, Umbilical1Product Code
- EYNTray, Irrigation, Sterile2Product Code
- FBQTrocar, Gastro-Urology2Product Code
- FZGApparatus, Air Handling, Bench2Product Code
- FZHApparatus, Air Handling, Room2Product Code
- FZIApparatus, Air Handling, Enclosure2Product Code
- GAXTourniquet, Nonpneumatic1Product Code
- KCWEpilator, High Frequency, Needle-Type1Product Code
- K954031COMPU-BLEND EPILATOR1Cleared 510(K)
- K952611STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION1Cleared 510(K)
- K945192HAIR REMOVAL SYSTEM1Cleared 510(K)
- K943928APILUS ELECTROPIL1Cleared 510(K)
- K943398THE BLENDTONE ROYALE1Cleared 510(K)
- K943399THE SS-991Cleared 510(K)
- K943396THE ELITE SPECTRUM1Cleared 510(K)
- K941227SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL1Cleared 510(K)
- K931063THE ELITE EPILATOR1Cleared 510(K)
- K931062THE VP500 EPILATOR1Cleared 510(K)
- Show All 43 Submissions
- KCXEpilator, High Frequency, Tweezer-Type1Product Code
- KCYTourniquet, Pneumatic1Product Code
- KPJChamber, Oxygen, Topical, Extremity2Product Code
- OJSTourniquet Kit1Product Code
- OLIFat Reducing Low Level Laser2Product Code
- PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use2Product Code
- QGXGeneral Use Pneumatic Tourniquet1Product Code
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
THE SS-99
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K943399
- 510(k) Type
- Traditional
- Applicant
- INSTANTRON
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 9/16/1994
- Days to Decision
- 64 days
- Submission Type
- Statement