Model: Electropil
Catalog: 01-1210
DI: 00686209051212
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-12
Current Version: 2026-05-20
Distribution End: 2026-05-12
Description
needle-type epilator
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
31a7a133-0dd6-437e-9f58-a7c19dc6df6f
Distribution Status:
Not in Commercial Distribution
DUNS Number:
246237945
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00686209051212
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 43642
Name: Professional hair-removal electrolysis system
Definition:
An assembly of devices intended to permanently remove unwanted body hair by destroying the dermal papilla (hair root) through application of an electric current at the tip of a fine needle electrode that is inserted close to the hair shaft, under the skin, and into the dermal papilla. It typically includes an electrically-powered control unit, a handpiece that connects to the control unit and holds the disposable electrode, and a foot-switch. The system is typically available in three types: galvanic (applies DC), thermolysis/high-frequency (applies AC), and blend (applies DC/AC combination). It is intended to be operated by a trained professional and may be referred to as an epilator.
FDA Product Codes
KCW
Epilator, High Frequency, Needle-Type