LCC
6 FDA 510(k) clearances · Product code
78 daysmedian time to decision
218 days90th percentile
6clearances measured
FDA profile
- Official device name
- Applicator, Ocular Pressure
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4610
- Medical specialty
- Ophthalmic
- Flags
- Third-party review eligible
- Adverse events (MAUDE)
- 1999: 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 |
|---|---|---|
| ILWAIT TIMER OCULOPRESSOR (K112952) | Oryx Medical Pty, Ltd. | 2012-05-10 |
| WEE BAG O'MERCURY (K946194) | Microsurgical Technology, Inc. | 1995-02-27 |
| OCULAR PRESSURE REDUCER (MCCANNEL) (K852032) | Visitec Co. | 1985-08-12 |
| WEE BAG O'MERCURY (K840004) | Surgi-Quip Inc.U | 1984-03-22 |
| RELIEF VALVE-HONAN INTRAOC. PRESSURE (K820526) | The Lebanon Corp. | 1982-03-25 |
| NEVYAS AUTOPRESS EYE COMPRESSOR (K792255) | Keeler Optical Products , Ltd. | 1979-12-11 |
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Every clearance here is in the API, with alerts when new ones post.