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510(k) K911983

WIZARD STERILIZED ELECTROEPILATION NEEDLE by Skin Deep, Inc. — Product Code KCW

K911983 is an FDA 510(k) premarket notification submitted by Skin Deep, Inc. for the device "WIZARD STERILIZED ELECTROEPILATION NEEDLE". The FDA issued a decision of Substantially Equivalent on October 15, 1991. The device falls under product code KCW (Epilator, High Frequency, Needle-Type), a Class I device regulated under 21 CFR 878.5350. Skin Deep, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1991
Date Received
May 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epilator, High Frequency, Needle-Type
Device Class
Class I
Regulation Number
878.5350
Review Panel
SU
Submission Type

Other clearances by Skin Deep, Inc.

  • K874891 — FLEXIE THE COPPER SHANK NEEDLE (January 7, 1988)

Other clearances for product code KCW

  • K954031 — COMPU-BLEND EPILATOR (January 5, 1996)
  • K952611 — STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION (October 18, 1995)
  • K943928 — APILUS ELECTROPIL (January 12, 1995)
  • K945192 — HAIR REMOVAL SYSTEM (January 12, 1995)
  • K943396 — THE ELITE SPECTRUM (September 16, 1994)
  • K943398 — THE BLENDTONE ROYALE (September 16, 1994)
  • K943399 — THE SS-99 (September 16, 1994)
  • K941227 — SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL (August 18, 1994)
  • K931063 — THE ELITE EPILATOR (July 8, 1993)
  • K931062 — THE VP500 EPILATOR (July 8, 1993)

FDA data resources