Identity
- Trade Name
- NEWHAIR LASER HAIR GROWTH CAP FDA UDI
- Generic Name
- Hair growth laser device FDA UDI
- Device Name
- 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 80 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. FDA UDI
- Model / Reference
- TW080 FDA UDI
- 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 80 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719892820806 FDA UDI
- 510(k) Number
- K192627 FDA UDI
- FDA Product Code
- OAP FDA UDI
- GMDN Term
- Hair growth laser device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hair growth laser device
Newhair Laser Hair Growth Cap by Shang Far Biotechnology Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hair growth laser device.
- Capillus — Capillus, LLC · Class II
- Xtrallux™ — Xtrallux, LLC · Class II
- Diode Laser Cap — Cosmo Far East Technology Limited · Class II
- Hair Boom69, Hair Boom — WONTECH CO., LTD · Class II
- HairMax — Lexington International, LLC · Class II
- RedRestore — 10589578 Canada Inc. · Class II
- Hairmax — Lexington International, LLC · Class II
- HairMax — Lexington International, LLC · Class II
Cleared under the same submission
K192627 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shang Far Biotechnology Co.
Sources (1)
- FDA UDI 2419ef0f-9129-4a1e-b653-a778aabc30bb 34 fields · synced May 31, 2026