Identity
- Trade Name
- TFX-LT2000 Therapy Light FDA UDI
- Generic Name
- Nail laser phototherapy unit FDA UDI
- Device Name
- Light therapy device for onychomycosis FDA UDI
- Model / Reference
- TFX-LT2000 FDA UDI
- Description
- Light therapy device for onychomycosis FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00086001245602 FDA UDI
- FDA Product Code
- PDZ FDA UDI
- GMDN Term
- Nail laser phototherapy unit 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Nail laser phototherapy unit
TFX-LT2000 Therapy Light by Toefx, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nail laser phototherapy unit.
- Lunula — Erchonia Corporation · Class II
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- LightForce EXP — LITECURE LLC · Class II
- GIGAA — Gigaalaser Company Ltd. · 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
- Toefx, Inc.
Sources (1)
- FDA UDI 75a008d8-92db-4712-b67f-a9492f269e31 33 fields · synced Jun 1, 2026