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510(k) K973773

DAPELLE HAIR REMOVER by Wellquest Intl., Inc. — Product Code KCX

K973773 is an FDA 510(k) premarket notification submitted by Wellquest Intl., Inc. for the device "DAPELLE HAIR REMOVER". The FDA issued a decision of Substantially Equivalent on December 17, 1997. The device falls under product code KCX (Epilator, High Frequency, Tweezer-Type), a Class I device regulated under 21 CFR 878.5360. Wellquest Intl., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1997
Date Received
October 2, 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 Wellquest Intl., Inc.

  • K132518 — NUBRILLIANCE PULSED LIGHT HAIR REMOVAL DEVICE (August 17, 2014)

Other clearances for product code KCX

  • K973340 — TWEEZER-TYPE EPILATOR (December 3, 1997)
  • K973174 — SONIQUE HAIR REMOVER (October 30, 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