NECOLLAGE (Opatra) TN2037
NECOLLAGE (Opatra) TN2037 (112A) is a Class II device made by iSMART Developments, Ltd., listed in FDA GUDID since 5 May 2021 (UDI-DI 05060534510203), 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 | Number05060534510203 | Date5 May 2021 | StatusListed |
Official records
- AccessGUDID record 05060534510203
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- NECOLLAGE (Opatra)
- Generic name
- Cosmetic red-light phototherapy system, home-use
- Model / Ref / Catalog
- TN2037, 112A
- Primary DI / UDI-DI
- 05060534510203
- FDA product code
- ILY
- GMDN term
- Cosmetic red-light phototherapy system, home-use
- Device class
- Class II
- Regulation number
- 890.5500
- GUDID distribution status
- In Commercial Distribution
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