Home / 510(k) Clearances / K945192

510(k) K945192

HAIR REMOVAL SYSTEM by L.P. Systems Corp. — Product Code KCW

K945192 is an FDA 510(k) premarket notification submitted by L.P. Systems Corp. for the device "HAIR REMOVAL SYSTEM". The FDA issued a decision of Substantially Equivalent on January 12, 1995. The device falls under product code KCW (Epilator, High Frequency, Needle-Type), a Class I device regulated under 21 CFR 878.5350. L.P. Systems Corp. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1995
Date Received
October 24, 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 L.P. Systems Corp.

  • K820650 — LPS 1118 (April 29, 1982)

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)
  • K943398 — THE BLENDTONE ROYALE (September 16, 1994)
  • K943396 — THE ELITE SPECTRUM (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