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510(k) K881276

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

K881276 is an FDA 510(k) premarket notification submitted by Ime Co. , Ltd. for the device "HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS". The FDA issued a decision of Substantially Equivalent on May 4, 1988. 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 4, 1988
Date Received
March 25, 1988
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.

  • K864869 — HR-5000 ELECTROSURGICAL DEVICE (May 19, 1987)

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)
  • K943398 — THE BLENDTONE ROYALE (September 16, 1994)
  • K943396 — THE ELITE SPECTRUM (September 16, 1994)
  • K943399 — THE SS-99 (September 16, 1994)
  • K941227 — SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL (August 18, 1994)
  • K931063 — THE ELITE EPILATOR (July 8, 1993)
  • K931062 — THE VP500 EPILATOR (July 8, 1993)

FDA data resources