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510(k) K905125

GUARANTY HAIR REMOVAL SYSTEM by Stephens Mfg. Co. — Product Code KCX

K905125 is an FDA 510(k) premarket notification submitted by Stephens Mfg. Co. for the device "GUARANTY HAIR REMOVAL SYSTEM". The FDA issued a decision of Substantially Equivalent on Aug 5, 1991. 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
Aug 5, 1991
Date Received
Nov 14, 1990
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
510(k) Exempt

Other clearances for product code KCX

  • K973773 — DAPELLE HAIR REMOVER (Dec 17, 1997)
  • K973340 — TWEEZER-TYPE EPILATOR (Dec 3, 1997)
  • K973174 — SONIQUE HAIR REMOVER (Oct 30, 1997)
  • K973179 — FEMINIQUE SONIC HAIR REMOVER (Oct 30, 1997)
  • K972695 — FINALLY FREE (Oct 22, 1997)
  • K970338 — TWEEZER-TYPE EPILATOR (Jul 1, 1997)
  • K935706 — EPI 2 (Feb 11, 1997)
  • K943872 — COMMANDER MARK II HAIR REMOVAL SYSTEM (Oct 26, 1995)
  • K952117 — EPILATOR (Oct 19, 1995)
  • K915845 — HAIR TRONICS MODEL HT8000 (Jul 29, 1992)

FDA data resources

Source: FDA 510(k) database entry for K905125. Report a data issue: hello@regdatalab.com.