FDA UDI
In Commercial Distribution
🇺🇸 United States
NEWHAIR LASER HAIR GROWTH CAP
DI: 04719892821476
·
Model: TW147
·
Shang Far Biotechnology Co.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NEWHAIR LASER HAIR GROWTH CAP
- Primary DI
- 04719892821476
- Version / Model
- TW147
- Company Name
- Shang Far Biotechnology Co.
- Labeler DUNS
- 658295570
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-11-30
- Public Version
- 1
- Public Version Date
- 2022-12-08
- Public Version Status
- New
- Public Device Record Key
- 1765a654-6536-4807-8f7d-bef6d6f1642e
Device Description
Laser Hair Growth Cap is a dome-shaped low level laser therapy (LLLT) device designed to promote hair growth in women and men by exposing the entire scalp to the photobiostimulation of 147 laser diodes. The Cap is designed with an outer plastic cover and a protective inner liner (containing the electronics and laser array) and is powered by an included battery pack.
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| OAP | Laser, Comb, Hair | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47417 | Hair growth laser device | An electronic, portable, head-worn or hand-operated device intended to be operated by a layperson affected by scalp hair loss (i.e., receding hairline/baldness due to androgenic alopecia) to stimulate hair growth on the scalp through the application of scheduled low-level laser therapy (LLLT). The device uses individual laser diodes to direct laser light at the scalp and may include features (e.g., a comb) to separate the user's hair to allow for improved penetration of the laser light. It is intended for use in the home or a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04719892821476 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K192627 | 000 |