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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 Oct 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 1 other 510(k) clearance on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Oct 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
510(k) Exempt

Other clearances by Skin Deep, Inc.

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

Other clearances for product code KCW

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

FDA data resources

Source: FDA 510(k) database entry for K911983. Report a data issue: hello@regdatalab.com.