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510(k) K894771

EPILATION NEEDLE by Precision Electrolysis Needles, Inc. — Product Code KCW

K894771 is an FDA 510(k) premarket notification submitted by Precision Electrolysis Needles, Inc. for the device "EPILATION NEEDLE". The FDA issued a decision of Substantially Equivalent on August 21, 1989. The device falls under product code KCW (Epilator, High Frequency, Needle-Type), a Class I device regulated under 21 CFR 878.5350.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 1989
Date Received
July 26, 1989
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 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)
  • 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)
  • K931062 — THE VP500 EPILATOR (July 8, 1993)
  • K931063 — THE ELITE EPILATOR (July 8, 1993)

FDA data resources