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510(k) K843735

SOFTEPIL by Nemectron Medical, Inc. — Product Code KCX

K843735 is an FDA 510(k) premarket notification submitted by Nemectron Medical, Inc. for the device "SOFTEPIL". The FDA issued a decision of Substantially Equivalent on October 25, 1984. The device falls under product code KCX (Epilator, High Frequency, Tweezer-Type), a Class I device regulated under 21 CFR 878.5360. Nemectron Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 1984
Date Received
September 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epilator, High Frequency, Tweezer-Type
Device Class
Class I
Regulation Number
878.5360
Review Panel
SU
Submission Type

Other clearances by Nemectron Medical, Inc.

  • K923396 — THERMODYN (May 26, 1993)
  • K895000 — NEMECTRON MICROWAVE (July 27, 1990)
  • K862376 — NEMECTROSON MODEL 2 (July 23, 1986)
  • K854720 — NEMECTRODYN MODEL 2 & ENDOVAC 2 POWER MUSCLE STIM. (March 10, 1986)
  • K854721 — NEMECTRODYN MODEL 2 & ENDOVAC 2 (March 6, 1986)
  • K844416 — THERMOPULS E (March 12, 1985)
  • K843734 — NEMDI (October 25, 1984)
  • K823511 — EMG BIOFEEDBACK DEVICE (March 31, 1983)
  • K820334 — NEMECTRODYN MODELS 8,7,5 (VOLS. I-IV (March 15, 1982)
  • K810513 — ELECTRODYN CII-INTERFERENTIAL MUSCLE (May 11, 1981)

Other clearances for product code KCX

  • K973773 — DAPELLE HAIR REMOVER (December 17, 1997)
  • K973340 — TWEEZER-TYPE EPILATOR (December 3, 1997)
  • K973174 — SONIQUE HAIR REMOVER (October 30, 1997)
  • K973179 — FEMINIQUE SONIC HAIR REMOVER (October 30, 1997)
  • K972695 — FINALLY FREE (October 22, 1997)
  • K970338 — TWEEZER-TYPE EPILATOR (July 1, 1997)
  • K935706 — EPI 2 (February 11, 1997)
  • K943872 — COMMANDER MARK II HAIR REMOVAL SYSTEM (October 26, 1995)
  • K952117 — EPILATOR (October 19, 1995)
  • K915845 — HAIR TRONICS MODEL HT8000 (July 29, 1992)

FDA data resources