510(k) K952117
- Device
- EPILATOR
- Applicant
- BURKE NEUTECH, INC.
- 510(k) number
- K952117
- Product code
- KCX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-10-19
- Date received
- 1995-05-05
- Regulation
- 878.5360
- Classification name
- Epilator, High Frequency, Tweezer-type
- Medical specialty
- General & Plastic Surgery
- Review panel
- General & Plastic Surgery
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT E BURKE
- Address
- 1765 Commerce Ave. N St. Petersburg FL US 33716 33716
FDA Registration Numbers#
- 3001620590
- 3002761766
- 3008936260
- 3003965134
- 3003998824
- 3013946322
- 3009523076
- 3006982887
- 3023216622
- 3010701675
- 3004892425
- 3013689783
- 8030950
- 3010595767
- 2518634
- 9681540
- 3013632692
- 3015143057
- 3016450032
- 3017555752
- 3015136927
- 1063974
- 3012292909
- 8040172
- 3017417635
- 3009381954
- 3009768364
- 3011529314
- 3031564283
- 3008808082
- 3016965929
- 3008650974
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code KCX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K973773 | DAPELLE HAIR REMOVER | Wellquest Intl., Inc. | 1997-12-17 |
| K973340 | TWEEZER-TYPE EPILATOR | Mobit, Inc. | 1997-12-03 |
| K973179 | FEMINIQUE SONIC HAIR REMOVER | Global TV Concepts, Ltd. | 1997-10-30 |
| K973174 | SONIQUE HAIR REMOVER | Global TV Concepts, Ltd. | 1997-10-30 |
| K972695 | FINALLY FREE | Mehl/Group Marketing | 1997-10-22 |
| K970338 | TWEEZER-TYPE EPILATOR | Igia Direct, Inc. | 1997-07-01 |
| K935706 | EPI 2 | Universal H.R. System, Inc. | 1997-02-11 |
| K943872 | COMMANDER MARK II HAIR REMOVAL SYSTEM | The Helene Edgar Corp. | 1995-10-26 |
| K915845 | HAIR TRONICS MODEL HT8000 | Global Tronics Intl., Inc. | 1992-07-29 |
| K905125 | GUARANTY HAIR REMOVAL SYSTEM | Stephens Mfg. Co. | 1991-08-05 |
| K892514 | AHRS EPILATOR 629 | American Hair Removal System Co. | 1990-08-14 |
| K851413 | EPILATOR 8500 | Lois Yee Cosmetics, Inc. | 1985-06-10 |
| K843735 | SOFTEPIL | Nemectron Medical, Inc. | 1984-10-25 |
| K843734 | NEMDI | Nemectron Medical, Inc. | 1984-10-25 |
| K770791 | DEPILATOR, DERMA-I & DERMA-II | Electro-Kinetic Eng/Mfg | 1981-01-26 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases