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510(k) K895687

D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE) by Carol Block, Ltd. — Product Code KCW

K895687 is an FDA 510(k) premarket notification submitted by Carol Block, Ltd. for the device "D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE)". The FDA issued a decision of Substantially Equivalent on Aug 9, 1990. 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
Aug 9, 1990
Date Received
Sep 22, 1989
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 for product code KCW

  • K954031 — COMPU-BLEND EPILATOR (Jan 5, 1996)
  • K952611 — STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION (Oct 18, 1995)
  • K943928 — APILUS ELECTROPIL (Jan 12, 1995)
  • K945192 — HAIR REMOVAL SYSTEM (Jan 12, 1995)
  • K943398 — THE BLENDTONE ROYALE (Sep 16, 1994)
  • K943396 — THE ELITE SPECTRUM (Sep 16, 1994)
  • K943399 — THE SS-99 (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)

FDA data resources

Source: FDA 510(k) database entry for K895687. Report a data issue: hello@regdatalab.com.