FDA UDI
In Commercial Distribution
🇺🇸 United States
Solawave
DI: 00850035134887
·
Model: HD-15A
·
Shenzhen Kaiyan Medical Equipment Co,. Ltd
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Solawave
- Primary DI
- 00850035134887
- Version / Model
- HD-15A
- Company Name
- Shenzhen Kaiyan Medical Equipment Co,. Ltd
- Labeler DUNS
- 543062382
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-01-30
- Public Version
- 1
- Public Version Date
- 2024-02-07
- Public Version Status
- New
- Public Device Record Key
- 2892412b-f53c-4869-8cf6-0655d0d4f025
Device Description
The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- 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 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47704 | Cosmetic red-light phototherapy system, home-use | An assembly of mains electricity (AC-powered) devices designed to emit low-level broad-band (LLBB) red light in the visible and invisible spectra together with heat [light and heat energy (LHE)] for the cosmetic treatment of dermatological conditions in the home. It typically consists of an energy generator and an attached applicator to apply the energy to the skin. It is designed to be operated by the patient typically for self body hair removal, skin rejuvenation, vascular and pigmented lesion removal, wrinkle reduction, collagen renewal, acne clearance, and/or mild to moderate psoriasis care. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850035134887 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K232863 | 000 |