Micro-current Wrinkle Reduction Facial Service, Model EP-400
by Li-Tek Electronic Technology Corporation 510(k)
Active
510(k) K162106
Overview
The Micro-current Wrinkle Reduction Facial Service, Model EP-400 is a transcutaneous electrical stimulator designed for aesthetic purposes. Classified as a Stimulator, Transcutaneous Electrical, Aesthetic Purposes, it delivers micro-current stimulation via interchangeable electrode heads to promote facial muscle toning and reduce periorbital wrinkles. The device also incorporates a red LED head for targeted red light therapy on the under-eye area, addressing fine lines and skin texture.
This device is intended for over-the-counter use and operates via an internal rechargeable lithium battery. Supplied as a single-use or reusable system (as per user instructions), it requires no regulatory sterilisation and is not classified for MRI environments. The Model EP-400 is authorised under FDA 510(k) clearance (K162106) and falls under Device Class II (NFO product code). Storage and handling follow standard consumer-electronic guidelines, with no additional regulatory restrictions stated.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162106 | Date3 Feb 2017 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- NFO
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Li-Tek Electronic Technology Corporation
Questions
What is the primary purpose of the Micro-current Wrinkle Reduction Facial service, Model EP-400, and how does it work?
The Micro-current Wrinkle Reduction Facial service, Model EP-400, is designed for aesthetic purposes to promote facial muscle toning and reduce periorbital wrinkles. It achieves this through transcutaneous electrical stimulation delivered via interchangeable electrode heads, which gently contract facial muscles to improve tone. Additionally, it includes a red LED head for targeted red light therapy on the under-eye area, targeting fine lines and skin texture for a smoother appearance.
Is the device single-use or reusable, and what are the storage requirements?
The Micro-current Wrinkle Reduction Facial service, Model EP-400, can be used either as a single-use or reusable system, depending on the user’s instructions. Since it is intended for over-the-counter use and does not require regulatory sterilization, storage follows standard consumer-electronic guidelines. This means it should be kept in a dry place, away from direct sunlight or extreme temperatures, and protected from physical damage.
Can this device be used in an MRI environment, and what power source does it use?
No, the Micro-current Wrinkle Reduction Facial service, Model EP-400, is not classified for use in MRI environments. The device operates via an internal rechargeable lithium battery, eliminating the need for external power sources during use.
What regulatory approval does the Micro-current Wrinkle Reduction Facial service, Model EP-400, hold, and what class does it belong to?
The Micro-current Wrinkle Reduction Facial service, Model EP-400, holds FDA 510(k) clearance under the classification of a Stimulator, Transcutaneous Electrical, for Aesthetic Purposes. It is classified as a Device Class II product under the NFO (New and Full of Use) product code, indicating it has been determined to be substantially equivalent to a legally marketed device.