Identity
- Trade Name
- FoLix™ Handpiece FDA UDI
- Generic Name
- Hair growth therapy laser system FDA UDI
- Model / Reference
- NA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290117772539 FDA UDI
- FDA Product Code
- GEX FDA UDIONG FDA UDI
- GMDN Term
- Hair growth therapy laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
Yes
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
Yes
FDA UDI
Category: Hair growth therapy laser system
FoLix™ Handpiece by Lumenis Be, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Hair growth therapy laser system.
- FoLix™ — Lumenis Be, Inc. · Class II
- FoLiCool™ Tip — Lumenis Be, Inc. · 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
- Lumenis Be, Inc.
Sources (1)
- FDA UDI 96010537-4f59-4aff-b073-a2f5c3923905 32 fields · synced May 30, 2026