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510(k) K973340

TWEEZER-TYPE EPILATOR by Mobit, Inc. — Product Code KCX

K973340 is an FDA 510(k) premarket notification submitted by Mobit, Inc. for the device "TWEEZER-TYPE EPILATOR". The FDA issued a decision of Substantially Equivalent on December 3, 1997. The device falls under product code KCX (Epilator, High Frequency, Tweezer-Type), a Class I device regulated under 21 CFR 878.5360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1997
Date Received
September 5, 1997
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 for product code KCX

  • K973773 — DAPELLE HAIR REMOVER (December 17, 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)
  • K905125 — GUARANTY HAIR REMOVAL SYSTEM (August 5, 1991)

FDA data resources