MUW
6 FDA 510(k) clearances · Product code
84 daysmedian time to decision
194 days90th percentile
6clearances measured
FDA profile
- Official device name
- Lens, Contact (Orthokeratology)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.5916
- Medical specialty
- Ophthalmic
- Adverse events (MAUDE)
- 1999: 3 · 2006: 2
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 |
|---|---|---|
| iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses (K183200) | C&E GP Specialist, Inc. | 2019-01-09 |
| OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) (K160859) | Contamac, Ltd. | 2016-07-13 |
| FLUOROPERM 151-OK, PARAGON HDS 100-OK (K010109) | Paragon Vision Sciences | 2001-02-28 |
| BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY (K003933) | Polymer Technology | 2001-02-16 |
| FLUROPERM 60-OK, PARAGON HDS-OK (K000224) | Paragon Vision Sciences | 2000-04-17 |
| AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY (K973697) | Airperm, Inc. | 1998-04-08 |
Track MUW automatically
Every clearance here is in the API, with alerts when new ones post.