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510(k) K883892

BALLET STERILE DISPOSABLE ELECTROLYSIS by Synoptic Products — Product Code KCW

K883892 is an FDA 510(k) premarket notification submitted by Synoptic Products for the device "BALLET STERILE DISPOSABLE ELECTROLYSIS". The FDA issued a decision of Substantially Equivalent on October 20, 1988. 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 20, 1988
Date Received
September 14, 1988
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