FDA 510(k) clearances: Needle epilators
Beginning on 28 May 1976, the US Food and Drug Administration (FDA) began requiring new medical devices to demonstrate they were "substantially equivalent" to a product marketed before 1976.
On 16 January 1996, FDA reclassified needle epilators and no longer requires them to submit 510(k) data.
See
FDA needle reclassification
FDA classifies needle epilators and accessories as follows:
- Device Classification Name: Epilator, needle-type
- Regulation Number: 878.5350
- Product Code: KCW
Product Code KCW
Needle epilators and accessories cleared by FDA, 1976-1996
Note: Any needle epilator marketed since 16 January 1996 will not be listed below, but that does not mean that the device is any more or less safe or effective than devices that were required to get clearance.
| Device | Company | Date cleared | 510(k) |
| Compu-Blend Epilator | R.A. Fischer | 01/05/96 | K954031 |
| Sterex Sterile Disposable Needle | Sterex | 10/18/95 | K952611 |
| Apilus Electroepil | Dectro | 01/12/95 | K943928 |
| Hair Removal System | L.P. Systems | 01/12/95 | K945192 |
| Elite Spectrum | Instantron | 09/16/94 | K943396 |
| Blendtone Royale | Instantron | 09/16/94 | K943398 |
| SS-99 | Instantron | 09/16/94 | K943399 |
| Shortwave Epilator | Instantron | 08/18/94 | K941227 |
| VP500 Epilator | Instantron | 07/08/93 | K931062 |
| Elite Epilator | Instantron | 07/08/93 | K931063 |
| Blendtone Epilator | Instantron | 07/08/93 | K931064 |
| Wizard Sterilized Electroepilation Needle | Skin Deep | 10/15/91 | K911983 |
| Electro-Blend Epilator, Model UC-3 | A.R. Hinkel | 10/04/90 | K904015 |
| D’Plume XXII Photocoagulator [1] | Carol Block | 08/09/90 | K895687 |
| Epilation Needle | Precision | 08/21/89 | K894771 |
| Model SE-5 Epilator | R.A. Fischer | 06/05/89 | K893389 |
| Ballet Sterile Disposable Needle | Synoptic Products | 10/20/88 | K883892 |
| Model CBX Epilator | R.A. Fischer | 10/04/88 | K884079 |
| HR-5000 Electosurgical Device | IME Co. | 05/04/88 | K881276 |
| Electronic Epilator | Clareblend | 02/29/88 | K880553 |
| Flexie Copper Shank Needle | Skin Deep | 01/07/88 | K874891 |
| HR-5000 Electosurgical Device | IME Co. | 05/19/87 | K864869 |
| CB-7 Electronic Epilator | R.A. Fischer | 04/28/87 | K871372 |
| High Frequency Needle-Type Epilator | Multi-Channel (Gentronics) | 12/24/86 | K864291 |
| Microprocessor Control/MNG Epilator | Alexander Thomas | 12/01/86 | K864289 |
| Berkowits 2200 Short Wave Epilator [2] | Berkowits | 02/05/86 | K860056 |
| Guibor Microelectrolysis Unit 18 | Galvanic Medical | 08/20/85 | K851318 |
| Electronic Epilator TS-1 | R.A. Fischer | 09/26/84 | K843063 |
| Epitron Super | Leo Unlimited | 04/23/84 | K834572 |
| Epilot 80 S TM | Leo Unlimited | 04/04/84 | K833946 |
| Tufcote Epilation Probe | Serapis Medical | 08/12/83 | K831048 |
| High Frequency Epilator CB-2 | R.A. Fischer | 01/14/83 | K823674 |
| LPS 1118 | L.P. Systems | 04/29/82 | K820650 |
| Stoltronics-LRS | Stoltronic Systems | 02/04/82 | K813637 |
| Epilator, Multiple Needle-Model EM-20 | RCX-Western | 07/10/81 | K811501 |
| Epilator, Blend-Model EB-200 & ET-1 | RCX-Western | K811503 | 07/10/81 |
| Epilatron | Electrola | 05/08/81 | K810843 |
| Compact Model 360 Galvanic Epilator | Associated Electrolysis | 08/04/80 | K801555 |
| Epilator, Ease-Multi-Mode | Greenleaf-Carter | 10/10/78 | K781147 |
| Thermolysis Generator | Clareblend | 04/12/78 | K780337 |
| Epilator, Electronic Model SE-2 | R.A. Fischer | 01/24/78 | K780076 |
[1] The D’Plume XXII device currently marketed is not a needle epilator, but a photoepilator.
[2] The Berkowits device currently marketed is not a needle epilator, but an electric tweezer.
Sources: