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510(k) K943872

COMMANDER MARK II HAIR REMOVAL SYSTEM by The Helene Edgar Corp. — Product Code KCX

K943872 is an FDA 510(k) premarket notification submitted by The Helene Edgar Corp. for the device "COMMANDER MARK II HAIR REMOVAL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 26, 1995. 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
October 26, 1995
Date Received
August 8, 1994
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)
  • 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)
  • K952117 — EPILATOR (October 19, 1995)
  • K915845 — HAIR TRONICS MODEL HT8000 (July 29, 1992)
  • K905125 — GUARANTY HAIR REMOVAL SYSTEM (August 5, 1991)

FDA data resources