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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 Jan 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 12 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Jan 5, 1996
Date Received
Aug 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
510(k) Exempt

Other clearances by R. A. Fischer Co. Corp.

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

Other clearances for product code KCW

  • K952611 — STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION (Oct 18, 1995)
  • K945192 — HAIR REMOVAL SYSTEM (Jan 12, 1995)
  • K943928 — APILUS ELECTROPIL (Jan 12, 1995)
  • K943399 — THE SS-99 (Sep 16, 1994)
  • K943396 — THE ELITE SPECTRUM (Sep 16, 1994)
  • K943398 — THE BLENDTONE ROYALE (Sep 16, 1994)
  • K941227 — SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL (Aug 18, 1994)
  • K931062 — THE VP500 EPILATOR (Jul 8, 1993)
  • K931063 — THE ELITE EPILATOR (Jul 8, 1993)
  • K931064 — THE BLENDTONE EPILATOR (Jul 8, 1993)

FDA data resources

Source: FDA 510(k) database entry for K954031. Report a data issue: hello@regdatalab.com.