iStand
iStand (700-48491-001) is a Class II device made by Optovue, Inc., cleared under FDA 510(k) K103266 on 3 Jun 2011 and listed in FDA GUDID since 3 Aug 2016 (UDI-DI 00858848006285), active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00858848006285 | Date3 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK103266 | Date3 Jun 2011 | StatusActive |
Official records
- AccessGUDID record 00858848006285
- FDA 510(k) database K103266
Across registries
- FDA 510(k) K103266 decided 3 Jun 2011 Active
- FDA GUDID UDI-DI 00858848006285 listed 3 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K103266
- Listed FDA GUDID 00858848006285
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Static ophthalmic equipment stand, electrically-adjusted
- Model / Ref / Catalog
- iStand, 700-48491-001
- Primary DI / UDI-DI
- 00858848006285
- 510(k) Number
- FDA product code
- HLI
- GMDN term
- Static ophthalmic equipment stand, electrically-adjusted
- Device class
- Class II
- Regulation number
- 886.1570
- GUDID distribution status
- In Commercial Distribution
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