HQN
7 FDA 510(k) clearances · Product code
126 daysmedian time to decision
232 days90th percentile
7clearances measured
FDA profile
- Official device name
- Conformer, Ophthalmic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.3130
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1994: 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 |
|---|---|---|
| MEDPOR OCULAR CONFORMER (K972034) | Porex Surgical, Inc. | 1998-01-20 |
| OCULAR CONFORMER (K970319) | Xavier A. Guerra, Ocularist, Inc. | 1997-07-07 |
| OCULAR CONFORMER (K970318) | Southwest Artificial Eyes, Inc. | 1997-07-07 |
| KOLBERG OPHTHALMIC CONFORMER (K945110) | Kolberg Ocular Products, Inc. | 1995-01-13 |
| STERILE/SINGLE USE SYMBLEPHARON RING (K921221) | Storz Instrument Co. | 1992-07-17 |
| STERILE/SINGLE USE OPHTHALMIC CONFORMERS (K921229) | Storz Instrument Co. | 1992-06-09 |
| MOLDEYE (K772168) | Robert B. Scott Ocularists of Florida, Inc. | 1977-11-30 |
Track HQN automatically
Every clearance here is in the API, with alerts when new ones post.