handLITE TN19S
handLITE TN19S (125A) is a Class II device made by iSMART Developments, Ltd., listed in FDA GUDID since 5 May 2021 (UDI-DI 05060534510241), registry data as of 23 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number05060534510241 | Date5 May 2021 | StatusListed |
Official records
- AccessGUDID record 05060534510241
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- handLITE
- Generic name
- Red/infrared light phototherapy unit
- Model / Ref / Catalog
- TN19S, 125A
- Primary DI / UDI-DI
- 05060534510241
- FDA product code
- ILY
- GMDN term
- Red/infrared light phototherapy unit
- Device class
- Class II
- Regulation number
- 890.5500
- GUDID distribution status
- In Commercial Distribution
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