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510(k) K954031

COMPU-BLEND EPILATOR by R. A. Fischer Co. Corp. — Product Code KCW

K954031 is an FDA 510(k) premarket notification submitted by R. A. Fischer Co. Corp. for the device "COMPU-BLEND EPILATOR". The FDA issued a decision of Substantially Equivalent on January 5, 1996. The device falls under product code KCW (Epilator, High Frequency, Needle-Type), a Class I device regulated under 21 CFR 878.5350. R. A. Fischer Co. Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 5, 1996
Date Received
August 28, 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 by R. A. Fischer Co. Corp.

  • K964208 — MD-1A GALVANIC UNIT (April 30, 1997)
  • K895365 — MD-2 IONTOPHORESIS UNIT (June 26, 1990)
  • K893389 — MODEL SE-5 EPILATOR (June 5, 1989)
  • K884079 — MODEL CBX EPILATOR (October 4, 1988)
  • K871372 — CB-7 ELECTRONIC EPILATOR (April 28, 1987)
  • K852534 — ULTRAVIOLET TREATMENT LAMPS UV-8 & UV-9 (November 8, 1985)
  • K843063 — ELECTRONIC EPILATOR TS-1 (September 26, 1984)
  • K823674 — HIGH FREQUENCY EPILATOR CB-2 (January 14, 1983)
  • K801351 — EPILATOR, MODEL CP-16 (July 28, 1980)
  • K780076 — EPILATOR, ELECTRONIC MODEL SE-2 (January 24, 1978)

Other clearances for product code KCW

  • 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)
  • 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