Identity
- Trade Name
- Hairmax FDA UDI
- Generic Name
- Hair growth laser device FDA UDI
- Device Name
- Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT) FDA UDI
- Model / Reference
- Pro 12 LaserComb FDA UDI
- Description
- Hair Growth Laser Light Device - Low Level Laser Therapy (LLLT) FDA UDI
Identifiers
- Catalog Number
- 850016973481 FDA UDI
- Primary DI / UDI-DI
- 00850016973481 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
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hair growth laser device
Hairmax by Lexington International, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Hair growth laser device.
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- Capillus — Capillus, LLC · Class II
- EXOCEUTICALS — Shenzhen Kaiyan Medical Equipment Co, . Ltd · Class II
- Capillus — Capillus, 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
- Lexington International, LLC
Sources (1)
- FDA UDI 6354c0d8-698f-434e-bba2-1786b24ebc4e 34 fields · synced May 30, 2026