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510(k) K952611

STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION by Sterex Electrolysis Intl., Ltd. — Product Code KCW

K952611 is an FDA 510(k) premarket notification submitted by Sterex Electrolysis Intl., Ltd. for the device "STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION". The FDA issued a decision of Substantially Equivalent on October 18, 1995. 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
October 18, 1995
Date Received
June 7, 1995
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)
  • K945192 — HAIR REMOVAL SYSTEM (January 12, 1995)
  • K943928 — APILUS ELECTROPIL (January 12, 1995)
  • K943399 — THE SS-99 (September 16, 1994)
  • K943396 — THE ELITE SPECTRUM (September 16, 1994)
  • K943398 — THE BLENDTONE ROYALE (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)
  • K931064 — THE BLENDTONE EPILATOR (July 8, 1993)

FDA data resources