Identity
- Trade Name
- Irradiation Aesthetic Device FDA UDI
- Generic Name
- Hair growth laser device FDA UDI
- Device Name
- Irradiation Aesthetic Device (Model: HairPro) consists of laser diodes that are spread throughout the cap. The device uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after ach 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes. FDA UDI
- Model / Reference
- HairPro FDA UDI
- Description
- Irradiation Aesthetic Device (Model: HairPro) consists of laser diodes that are spread throughout the cap. The device uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. In the process of the cap working, the indicator blinks red based on the working frequency of the laser diodes. Built-in timing function, the cap can record the time per treatment, and the cap can stop working automatically after ach 30 minutes treatment. When the built-in IR detected the cap is not worn on the head, the laser light output will be automatically suspended immediately and the cap will automatically shut down after 10 minutes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06971777450029 FDA UDI
- 510(k) Number
- K171835 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Hair growth laser device
Irradiation Aesthetic Device by Chongqing Peninsula Medical Technology Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hair growth laser device.
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- 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
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
- Chongqing Peninsula Medical Technology Co., Ltd.
Sources (1)
- FDA UDI 0cea493b-a264-454d-b349-272cc7fb9f53 34 fields · synced Jun 1, 2026