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510(k) K864869

HR-5000 ELECTROSURGICAL DEVICE by Ime Co. , Ltd. — Product Code KCW

K864869 is an FDA 510(k) premarket notification submitted by Ime Co. , Ltd. for the device "HR-5000 ELECTROSURGICAL DEVICE". The FDA issued a decision of Substantially Equivalent on May 19, 1987. The device falls under product code KCW (Epilator, High Frequency, Needle-Type), a Class I device regulated under 21 CFR 878.5350. Ime Co. , Ltd. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 1987
Date Received
December 12, 1986
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 Ime Co. , Ltd.

  • K881276 — HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS (May 4, 1988)

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)
  • K945192 — HAIR REMOVAL SYSTEM (January 12, 1995)
  • K943396 — THE ELITE SPECTRUM (September 16, 1994)
  • K943398 — THE BLENDTONE ROYALE (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)

FDA data resources