Home / 510(k) Clearances / K943396

510(k) K943396

THE ELITE SPECTRUM by Instantron — Product Code KCW

K943396 is an FDA 510(k) premarket notification submitted by Instantron for the device "THE ELITE SPECTRUM". The FDA issued a decision of Substantially Equivalent on September 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 at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1994
Date Received
July 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

Other clearances by Instantron

  • K943398 — THE BLENDTONE ROYALE (September 16, 1994)
  • K943399 — THE SS-99 (September 16, 1994)
  • K941227 — SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL (August 18, 1994)
  • K931062 — THE VP500 EPILATOR (July 8, 1993)
  • K931063 — THE ELITE EPILATOR (July 8, 1993)
  • K931064 — THE BLENDTONE EPILATOR (July 8, 1993)

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)
  • K943928 — APILUS ELECTROPIL (January 12, 1995)
  • K945192 — HAIR REMOVAL SYSTEM (January 12, 1995)
  • K943398 — THE BLENDTONE ROYALE (September 16, 1994)
  • K943399 — THE SS-99 (September 16, 1994)
  • K941227 — SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL (August 18, 1994)
  • K931062 — THE VP500 EPILATOR (July 8, 1993)
  • K931063 — THE ELITE EPILATOR (July 8, 1993)
  • K931064 — THE BLENDTONE EPILATOR (July 8, 1993)

FDA data resources