Home / 510(k) Clearances / K915845

510(k) K915845

HAIR TRONICS MODEL HT8000 by Global Tronics Intl., Inc. — Product Code KCX

K915845 is an FDA 510(k) premarket notification submitted by Global Tronics Intl., Inc. for the device "HAIR TRONICS MODEL HT8000". The FDA issued a decision of Substantially Equivalent on July 29, 1992. The device falls under product code KCX (Epilator, High Frequency, Tweezer-Type), a Class I device regulated under 21 CFR 878.5360.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 1992
Date Received
December 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epilator, High Frequency, Tweezer-Type
Device Class
Class I
Regulation Number
878.5360
Review Panel
SU
Submission Type

Other clearances for product code KCX

  • K973773 — DAPELLE HAIR REMOVER (December 17, 1997)
  • K973340 — TWEEZER-TYPE EPILATOR (December 3, 1997)
  • K973179 — FEMINIQUE SONIC HAIR REMOVER (October 30, 1997)
  • K973174 — SONIQUE HAIR REMOVER (October 30, 1997)
  • K972695 — FINALLY FREE (October 22, 1997)
  • K970338 — TWEEZER-TYPE EPILATOR (July 1, 1997)
  • K935706 — EPI 2 (February 11, 1997)
  • K943872 — COMMANDER MARK II HAIR REMOVAL SYSTEM (October 26, 1995)
  • K952117 — EPILATOR (October 19, 1995)
  • K905125 — GUARANTY HAIR REMOVAL SYSTEM (August 5, 1991)

FDA data resources