Identity
- Trade Name
- UVBioTek FDA UDI
- Generic Name
- Ultraviolet phototherapy unit, professional FDA UDI
- Device Name
- Phototherapy Unit. UVB Narrowband. 3 connected panels, 2 panels adjustable. Mounted to wall or stand. 10 lamps, each 72" in height. FDA UDI
- Model / Reference
- Multi Directional FDA UDI
- Description
- Phototherapy Unit. UVB Narrowband. 3 connected panels, 2 panels adjustable. Mounted to wall or stand. 10 lamps, each 72" in height. FDA UDI
Identifiers
- Catalog Number
- MD3 FDA UDI
- Primary DI / UDI-DI
- B343MD3 FDA UDI
- 510(k) Number
- K134009 FDA UDI
- FDA Product Code
- FTC FDA UDI
- GMDN Term
- Ultraviolet phototherapy unit, professional 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
- Weight — 235 Pound FDA UDIArea/Surface Area — 2553 Square inch FDA UDI
Category: Ultraviolet phototherapy unit, professional
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
K134009 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 4ec68462-03e4-4f16-ab75-f06cdd3daaab 36 fields · synced May 31, 2026