510(k) K864869
- Device
- HR-5000 ELECTROSURGICAL DEVICE
- Applicant
- IME CO. LTD.
- 510(k) number
- K864869
- Product code
- KCW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1987-05-19
- Date received
- 1986-12-12
- Regulation
- 878.5350
- Classification name
- Epilator, High Frequency, Needle-type
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KEVIN G MCANANEY
- Address
- 1775 Pennsylvania Ave., NW Washington DC US 20006 20006
FDA Registration Numbers#
- 3019169621
- 3016053560
- 3005114964
- 9681366
- 3010132111
- 3002807315
- 3002807310
- 3027509245
- 3005180774
- 2085143
- 3030634227
- 3022320321
- 3005545844
- 3010164891
- 3039435282
- 2020958
- 3026294985
- 1225072
- 1000286794
- 9680762
- 3030263612
- 3006174295
- 8030962
- 3010363436
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KCW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K954031 | COMPU-BLEND EPILATOR | R. A. Fischer Co. Corp. | 1996-01-05 |
| K952611 | STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION | Sterex Electrolysis Intl., Ltd. | 1995-10-18 |
| K945192 | HAIR REMOVAL SYSTEM | L.P. Systems Corp. | 1995-01-12 |
| K943928 | APILUS ELECTROPIL | Dectro Intl., Inc. | 1995-01-12 |
| K943399 | THE SS-99 | Instantron | 1994-09-16 |
| K943398 | THE BLENDTONE ROYALE | Instantron | 1994-09-16 |
| K943396 | THE ELITE SPECTRUM | Instantron | 1994-09-16 |
| K941227 | SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL | Instantron | 1994-08-18 |
| K931062 | THE VP500 EPILATOR | Instantron | 1993-07-08 |
| K931063 | THE ELITE EPILATOR | Instantron | 1993-07-08 |
| K931064 | THE BLENDTONE EPILATOR | Instantron | 1993-07-08 |
| K911983 | WIZARD STERILIZED ELECTROEPILATION NEEDLE | Skin Deep, Inc. | 1991-10-15 |
| K904015 | ELECTRO-BLEND EPILATOR, MODEL UC-3 | A.R. Hinkel Co., Inc. | 1990-10-04 |
| K895687 | D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE) | Carol Block, Ltd. | 1990-08-09 |
| K894771 | EPILATION NEEDLE | Precision Electrolysis Needles, Inc. | 1989-08-21 |
Legacy Summary#
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FDA Review#
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