Anesthesiology
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- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—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)
- K943399THE SS-991Cleared 510(K)
- K943396THE ELITE SPECTRUM1Cleared 510(K)
- K943398THE BLENDTONE ROYALE1Cleared 510(K)
- K941227SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL1Cleared 510(K)
- K931064THE BLENDTONE EPILATOR1Cleared 510(K)
- K931063THE ELITE EPILATOR1Cleared 510(K)
- K931064THE BLENDTONE EPILATOR1Cleared 510(K)
- K911983WIZARD STERILIZED ELECTROEPILATION NEEDLE1Cleared 510(K)
- K904015ELECTRO-BLEND EPILATOR, MODEL UC-31Cleared 510(K)
- K895687D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE)1Cleared 510(K)
- K894771EPILATION NEEDLE1Cleared 510(K)
- K893389MODEL SE-5 EPILATOR1Cleared 510(K)
- K883892BALLET STERILE DISPOSABLE ELECTROLYSIS1Cleared 510(K)
- K884079MODEL CBX EPILATOR1Cleared 510(K)
- K883429LINDSTROM CORDLESS EPILATOR1Cleared 510(K)
- K881276HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS1Cleared 510(K)
- K880553ELECTRONIC EPILATOR1Cleared 510(K)
- K874891FLEXIE THE COPPER SHANK NEEDLE1Cleared 510(K)
- K864869HR-5000 ELECTROSURGICAL DEVICE1Cleared 510(K)
- K871372CB-7 ELECTRONIC EPILATOR1Cleared 510(K)
- K864291HIGH FREQUENCY NEEDLE-TYPE EPILATOR1Cleared 510(K)
- K864289MICROPROCESSOR CONTR/MULTI-NEEDLE, GALVAN EPILATOR1Cleared 510(K)
- K860056BERKOWITS 2200 SHORT WAVE (THERMOLYSIS EPILATOR)1Cleared 510(K)
- K851318GUIBOR MICROELECTROLYSIS UNIT 181Cleared 510(K)
- K843063ELECTRONIC EPILATOR TS-11Cleared 510(K)
- K834572EPITRON SUPER1Cleared 510(K)
- K833946EPILOT 80 S TM1Cleared 510(K)
- K831048TUFCOTE EPILATION PROBE1Cleared 510(K)
- K823674HIGH FREQUENCY EPILATOR CB-21Cleared 510(K)
- K820650LPS 11181Cleared 510(K)
- K813637STOLTRONICS-LRS1Cleared 510(K)
- K811503EPILATOR, BLEND-MODEL EB-200 & ET-11Cleared 510(K)
- K811501EPILATOR, MULTIPLE NEEDLE-MODEL EM-201Cleared 510(K)
- K810843EPILATRON1Cleared 510(K)
- K801555COMPACT MODEL 360 GALVANIC EPILATOR1Cleared 510(K)
- K801351EPILATOR, MODEL CP-161Cleared 510(K)
- K781147EPILATOR, EASE-MULTI-MODE1Cleared 510(K)
- K780337THERMOLYSIS GENERATOR1Cleared 510(K)
- K780076EPILATOR, ELECTRONIC MODEL SE-21Cleared 510(K)
- 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
EPILOT 80 S TM
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K833946
- 510(k) Type
- Traditional
- Applicant
- LEO UNLIMITED, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/4/1984
- Days to Decision
- 141 days