Identity
- Trade Name
- Ideainfrared FDA UDI
- Generic Name
- Red/infrared light phototherapy unit FDA UDI
- Device Name
- LED Red Therapy Light FDA UDI
- Model / Reference
- TLB105 FDA UDI
- Description
- LED Red Therapy Light FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974958310136 FDA UDI
- FDA Product Code
- ISA FDA UDI
- GMDN Term
- Red/infrared light phototherapy unit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.5660 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Cosmetic red-light phototherapy system, home-useRed/infrared light phototherapy unit
Ideainfrared by Shenzhen Idea Light Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Red/infrared light phototherapy unit.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Idea Light Limited
Sources (1)
- FDA UDI efb84ca9-50af-442e-b37e-bf5f44f2b082 33 fields · synced May 31, 2026