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510(k) K801351

EPILATOR, MODEL CP-16 by R. A. Fischer Co. Corp. — Product Code KCW

K801351 is an FDA 510(k) premarket notification submitted by R. A. Fischer Co. Corp. for the device "EPILATOR, MODEL CP-16". The FDA issued a decision of Substantially Equivalent on July 28, 1980. 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
July 28, 1980
Date Received
June 9, 1980
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)
  • K954031 — COMPU-BLEND EPILATOR (January 5, 1996)
  • 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)
  • K780076 — EPILATOR, ELECTRONIC MODEL SE-2 (January 24, 1978)

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)
  • K943398 — THE BLENDTONE ROYALE (September 16, 1994)
  • K943399 — THE SS-99 (September 16, 1994)
  • K943396 — THE ELITE SPECTRUM (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)

FDA data resources