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510(k) K943398

THE BLENDTONE ROYALE by Instantron — Product Code KCW

K943398 is an FDA 510(k) premarket notification submitted by Instantron for the device "THE BLENDTONE ROYALE". The FDA issued a decision of Substantially Equivalent on Sep 16, 1994. The device falls under product code KCW (Epilator, High Frequency, Needle-Type), a Class I device regulated under 21 CFR 878.5350. Instantron has 6 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Sep 16, 1994
Date Received
Jul 14, 1994
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 Instantron

  • 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)
  • K931064 — THE BLENDTONE EPILATOR (Jul 8, 1993)

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)
  • 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)
  • K931064 — THE BLENDTONE EPILATOR (Jul 8, 1993)

FDA data resources

Source: FDA 510(k) database entry for K943398. Report a data issue: hello@regdatalab.com.