Identity
- Trade Name
- C-Wave LED Mask for Neck & Décolleté FDA UDI
- Generic Name
- Red/infrared light phototherapy unit FDA UDI
- Device Name
- C-Wave LED Mask for Neck & Décolleté Beauty Pie- Rebranded Variant of TN2037 (LED Neck & Dec Device) FDA UDI
- Model / Reference
- TN2037 FDA UDI
- Description
- C-Wave LED Mask for Neck & Décolleté Beauty Pie- Rebranded Variant of TN2037 (LED Neck & Dec Device) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060534510999 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Red/infrared light phototherapy unit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5500 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
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Red/infrared light phototherapy unit
C-Wave LED Mask for Neck & Décolleté by iSMART Developments, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Red/infrared light phototherapy unit.
- LED RED Light Therapy Panel — Shenzhen RedV Medical Equipment CO., LTD · Class II
- Benilight — Benilight · Class II
- ZONN — Zonnsmart Science & Technology Co., Ltd · Class II
- LED Light Therapy Eye Mask — Shenzhen RedV Medical Equipment CO., LTD · Class II
- LED RED Light Therapy Panel — Shenzhen RedV Medical Equipment CO., LTD · Class II
- LED RED Light Therapy Panel — Shenzhen RedV Medical Equipment CO., LTD · Class II
- LED Light Therapy Neck Mask — Shenzhen RedV Medical Equipment CO., LTD · Class II
- 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- iSMART Developments, Ltd.
Sources (1)
- FDA UDI f3e07d88-edc1-4d0f-b062-05fd79bac473 34 fields · synced May 30, 2026