Identity
- Trade Name
- R11 Air FDA UDI
- Generic Name
- Red/infrared light phototherapy unit FDA UDI
- Device Name
- Low level Light System (red light LED and infrared LED) that applies 635nm light and 880nm light for Aesthtic use and for pain indications. FDA UDI
- Model / Reference
- R11-s-2848r1-1188i1 UP 12 FDA UDI
- Description
- Low level Light System (red light LED and infrared LED) that applies 635nm light and 880nm light for Aesthtic use and for pain indications. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04260489020425 FDA UDI
- 510(k) Number
- K202955 FDA UDI
- FDA Product Code
- OLI FDA UDIILY FDA UDI
- GMDN Term
- Red/infrared light phototherapy unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5400 FDA UDI890.5500 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: Red/infrared light phototherapy unit
R11 Air by KBL GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- LED Light Therapy Eye Mask — Shenzhen RedV Medical Equipment CO., 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
- KBL GmbH
Sources (1)
- FDA UDI a18e6928-123f-494d-98f4-8ba703b13989 34 fields · synced Jun 8, 2026