Identity
- Trade Name
- UVBioTek FDA UDI
- Generic Name
- Ultraviolet phototherapy unit, home-use FDA UDI
- Device Name
- Phototherapy Unit. UVB Narrow Band. Portable/Table top mounting. Home or Clinic Use. FDA UDI
- Model / Reference
- Mobile Lite FDA UDI
- Description
- Phototherapy Unit. UVB Narrow Band. Portable/Table top mounting. Home or Clinic Use. FDA UDI
Identifiers
- Catalog Number
- ML600 FDA UDI
- Primary DI / UDI-DI
- B343ML600 FDA UDI
- 510(k) Number
- K111049 FDA UDI
- FDA Product Code
- FTC FDA UDI
- GMDN Term
- Ultraviolet phototherapy unit, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4630 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
Dimensions & Sizes
- Size
- Area/Surface Area — 286 Square inch FDA UDIWeight — 50 Pound FDA UDI
Category: Ultraviolet phototherapy unit, home-use
UVBioTek by Medtek Lighting Corp — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K111049 also covers:
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
- Medtek Lighting Corp
Sources (1)
- FDA UDI b2f3127d-8995-4784-b408-067efb8ab8a0 36 fields · synced Jun 8, 2026