Identity
- Trade Name
- decoLITE FDA UDI
- Generic Name
- Cosmetic red-light phototherapy system, home-use FDA UDI
- Device Name
- Décolletage & Neck Device- decoLITE Branded FDA UDI
- Model / Reference
- TN2037 FDA UDI
- Description
- Décolletage & Neck Device- decoLITE Branded FDA UDI
Identifiers
- Catalog Number
- 112A FDA UDI
- Primary DI / UDI-DI
- 05060534510036 FDA UDI
- FDA Product Code
- ILY FDA UDI
- GMDN Term
- Cosmetic red-light phototherapy system, home-use 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: Cosmetic red-light phototherapy system, home-use
decoLITE by iSMART Developments, Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- iSMART Developments, Ltd.
Sources (1)
- FDA UDI 2c075c08-cd8a-44ba-b7b2-6fbe81d8bb52 35 fields · synced May 30, 2026