FDA 510(k) clearance: Needle-type epilators

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:

Releasable 510(k) Database (type in KCW under Product Code to list all needle epilator and accessory clearances)

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