Identity
- Trade Name
- Tanses TT-50 Series FDA UDI
- Generic Name
- Ultraviolet tanning device FDA UDI
- Device Name
- TT-50 Series tanning booth, model TT-50, 50 suntan lamps total FDA UDI
- Model / Reference
- TT-50 FDA UDI
- Description
- TT-50 Series tanning booth, model TT-50, 50 suntan lamps total FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850056256360 FDA UDI
- 510(k) Number
- K152412 FDA UDI
- FDA Product Code
- LEJ FDA UDI
- GMDN Term
- Ultraviolet tanning device FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4635 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultraviolet tanning device
Tanses TT-50 Series by Tanses Technologies Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K152412 also covers:
- Tanses T-32 Series — Tanses Technologies Inc
- Tanses T-32 Series — Tanses Technologies Inc
- Tanses T-32 Series — Tanses Technologies Inc
- Tanses T-32 Series — Tanses Technologies Inc
- Tanses T-32 Series — Tanses Technologies Inc
- Tanses T-32 Series — Tanses Technologies Inc
- Tanses T-32 Series — Tanses Technologies Inc
- Tanses T-32 Series — Tanses Technologies Inc
- Tanses T-32 Series — Tanses Technologies Inc
- Tanses T-32 Series — Tanses Technologies Inc
- Tanses T-32 Series — Tanses Technologies Inc
- Tanses T-32 Series — Tanses Technologies Inc
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
- Tanses Technologies Inc
Sources (1)
- FDA UDI e50c02b7-f8d8-4fb9-9a4b-8ff01b8b9947 35 fields · synced Jun 8, 2026