LCC · Applicator, Ocular Pressure
Ophthalmic · 21 CFR 886.4610 · Class 2
Overview
| Product Code | LCC |
|---|---|
| Device Name | Applicator, Ocular Pressure |
| Regulation | 21 CFR 886.4610 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
An ocular pressure applicator is a manual device that consists of a sphygmomanometer-type squeeze bulb, a dial indicator, a band, and bellows, intended to apply pressure on the eye in preparation for ophthalmic surgery.
Classification Rationale
Class II.
Cleared Devices (6)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K112952 | ILWAIT TIMER OCULOPRESSOR | Oryx Medical Pty, Ltd. | May 10, 2012 | SESE |
| K946194 | WEE BAG O'MERCURY | Microsurgical Technology, Inc. | Feb 27, 1995 | SESE |
| K852032 | OCULAR PRESSURE REDUCER (MCCANNEL) | Visitec Co. | Aug 12, 1985 | SESE |
| K840004 | WEE BAG O'MERCURY | Surgi-Quip Inc.U | Mar 22, 1984 | SESE |
| K820526 | RELIEF VALVE-HONAN INTRAOC. PRESSURE | The Lebanon Corp. | Mar 25, 1982 | SESE |
| K792255 | NEVYAS AUTOPRESS EYE COMPRESSOR | Keeler Optical Products , Ltd. | Dec 11, 1979 | SESE |
Top Applicants
- Visitec Co. — 1 clearance
- The Lebanon Corp. — 1 clearance
- Surgi-Quip Inc.U — 1 clearance
- Oryx Medical Pty, Ltd. — 1 clearance
- Microsurgical Technology, Inc. — 1 clearance
