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510(k) K973174

SONIQUE HAIR REMOVER by Global TV Concepts, Ltd. — Product Code KCX

K973174 is an FDA 510(k) premarket notification submitted by Global TV Concepts, Ltd. for the device "SONIQUE HAIR REMOVER". The FDA issued a decision of Substantially Equivalent on October 30, 1997. The device falls under product code KCX (Epilator, High Frequency, Tweezer-Type), a Class I device regulated under 21 CFR 878.5360. Global TV Concepts, Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 30, 1997
Date Received
August 25, 1997
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 by Global TV Concepts, Ltd.

  • K013707 — SOFTIQUE, MODEL GI 11001 (February 1, 2002)
  • K973179 — FEMINIQUE SONIC HAIR REMOVER (October 30, 1997)

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)
  • 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)
  • K915845 — HAIR TRONICS MODEL HT8000 (July 29, 1992)
  • K905125 — GUARANTY HAIR REMOVAL SYSTEM (August 5, 1991)

FDA data resources