HQT
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Shell, Scleral
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3800
- Medical specialty
- Ophthalmic
- Flags
- Implant
- Adverse events (MAUDE)
- 2003: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SCLERAL SHELL (K970320) | Xavier A. Guerra, Ocularist, Inc. | 1997-07-07 |
| SCLERAL SHELL (K970327) | Southwest Artificial Eyes, Inc. | 1997-07-07 |
| ARTIFICIAL SCLERAL SHELL (K904961) | Midwest Eye Laboratories, Inc. | 1991-08-30 |
| SIMMONS SHELL (K855105) | Mira, Inc. | 1986-03-31 |
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Every clearance here is in the API, with alerts when new ones post.