KCW · Epilator, High Frequency, Needle-Type
General, Plastic Surgery · 21 CFR 878.5350 · Class 1
Overview
| Product Code | KCW |
|---|---|
| Device Name | Epilator, High Frequency, Needle-Type |
| Regulation | 21 CFR 878.5350 |
| Device Class | Class 1 |
| Review Panel | General, Plastic Surgery |
Identification
A needle-type epilator is a device intended to destroy the dermal papilla of a hair by applying electric current at the tip of a fine needle that has been inserted close to the hair shaft, under the skin, and into the dermal papilla. The electric current may be high-frequency AC current, high-frequency AC combined with DC current, or DC current only.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
Recent Cleared Devices (20 of 43)
Showing 20 most recent of 43 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K954031 | COMPU-BLEND EPILATOR | R. A. Fischer Co. Corp. | Jan 5, 1996 | SESE |
| K952611 | STEREX STERILE DISPOSALE ELECTROLYSIS NEEDLE FOR USE IN EPILATION | Sterex Electrolysis Intl., Ltd. | Oct 18, 1995 | SESE |
| K945192 | HAIR REMOVAL SYSTEM | L.P. Systems Corp. | Jan 12, 1995 | SESE |
| K943928 | APILUS ELECTROPIL | Dectro Intl., Inc. | Jan 12, 1995 | SESE |
| K943399 | THE SS-99 | Instantron | Sep 16, 1994 | SESE |
| K943398 | THE BLENDTONE ROYALE | Instantron | Sep 16, 1994 | SESE |
| K943396 | THE ELITE SPECTRUM | Instantron | Sep 16, 1994 | SESE |
| K941227 | SHORTWAVE EPILATOR FOR PERMANENT HAIR REMOVAL | Instantron | Aug 18, 1994 | SESE |
| K931064 | THE BLENDTONE EPILATOR | Instantron | Jul 8, 1993 | SESE |
| K931063 | THE ELITE EPILATOR | Instantron | Jul 8, 1993 | SESE |
| K931062 | THE VP500 EPILATOR | Instantron | Jul 8, 1993 | SESE |
| K911983 | WIZARD STERILIZED ELECTROEPILATION NEEDLE | Skin Deep, Inc. | Oct 15, 1991 | SESE |
| K904015 | ELECTRO-BLEND EPILATOR, MODEL UC-3 | A.R. Hinkel Co., Inc. | Oct 4, 1990 | SESE |
| K895687 | D'PLUME XXII PHOTOCOAGULATOR (EPILATION MACHINE) | Carol Block, Ltd. | Aug 9, 1990 | SESE |
| K894771 | EPILATION NEEDLE | Precision Electrolysis Needles, Inc. | Aug 21, 1989 | SESE |
| K893389 | MODEL SE-5 EPILATOR | R. A. Fischer Co. Corp. | Jun 5, 1989 | SESE |
| K883892 | BALLET STERILE DISPOSABLE ELECTROLYSIS | Synoptic Products | Oct 20, 1988 | SESE |
| K884079 | MODEL CBX EPILATOR | R. A. Fischer Co. Corp. | Oct 4, 1988 | SESE |
| K883429 | LINDSTROM CORDLESS EPILATOR | A Place of Health & Beauty | Sep 28, 1988 | SESE |
| K881276 | HR-5000 ELECTROSURGICAL DEVICE FOR NEW INDICATIONS | Ime Co. , Ltd. | May 4, 1988 | SESE |
Top Applicants
- R. A. Fischer Co. Corp. — 8 clearances
- Instantron — 7 clearances
- Ime Co. , Ltd. — 2 clearances
- L.P. Systems Corp. — 2 clearances
- Leo Unlimited, Inc. — 2 clearances
