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510(k) K874891

FLEXIE THE COPPER SHANK NEEDLE by Skin Deep, Inc. — Product Code KCW

K874891 is an FDA 510(k) premarket notification submitted by Skin Deep, Inc. for the device "FLEXIE THE COPPER SHANK NEEDLE". The FDA issued a decision of Substantially Equivalent on January 7, 1988. 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
January 7, 1988
Date Received
December 1, 1987
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.

  • K911983 — WIZARD STERILIZED ELECTROEPILATION NEEDLE (October 15, 1991)

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)
  • K945192 — HAIR REMOVAL SYSTEM (January 12, 1995)
  • K943928 — APILUS ELECTROPIL (January 12, 1995)
  • K943398 — THE BLENDTONE ROYALE (September 16, 1994)
  • K943399 — THE SS-99 (September 16, 1994)
  • K943396 — THE ELITE SPECTRUM (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