FDA UDI
In Commercial Distribution
🇺🇸 United States
Fynelook
DI: 06979082450024
·
Model: CEC101
·
Shenzhen Dachi communication Co.,Ltd
Product Codes
3
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Fynelook
- Primary DI
- 06979082450024
- Version / Model
- CEC101
- Company Name
- Shenzhen Dachi communication Co.,Ltd
- Labeler DUNS
- 420650337
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-02
- Public Version
- 1
- Public Version Date
- 2025-12-10
- Public Version Status
- New
- Public Device Record Key
- d64bc383-371f-4c6d-987c-5fa11e2e775a
Device Description
The Microcurrent Facial Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, membrane cloth, conductive gel and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NFO | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | Neurology | 882.5890 | 2 |
| OHS | Light Based Over The Counter Wrinkle Reduction | General, Plastic Surgery | 878.4810 | 2 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59822 | Skin photodynamic therapy/phototherapy lamp | A portable, mains electricity (AC-powered) lamp intended to emit low-level narrow-band (LLNB) red light (e.g., 600-650nm) and blue light (e.g., 415-440nm) either separately or simultaneously for photodynamic therapy (PDT) applications (with photosensitizing agent) to treat skin disorders such as actinic keratosis and non-melanoma skin cancer, and for phototherapy applications (through modification of skin metabolism) to treat skin complaints such as acne, rosacea and sun spots. It uses light-emitting diodes (LEDs) to produce a heatless light source which may be used for treatment at multiple anatomical sites. It is intended to be used by a healthcare professional in a clinical setting. | No | Active |
| 61169 | Transcutaneous electrical stimulation probe | A non-sterile, hand-held, pen-like electrical conductor intended to be held against a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation]. It typically has a metallic tip for skin contact, sometimes using a conductive pad. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06979082450024 | GS1 |
Customer Contacts
- Phone
- +8675583142660
- [email protected]