Applicator, Ocular Pressure
An ocular pressure applicator is an ophthalmic instrument used to apply controlled pressure to the eye, typically to facilitate intraocular lens implantation, reduce intraocular pressure, or assist in other ophthalmic surgical or diagnostic procedures. It is classified as FDA Class 2, requiring 510(k) premarket notification. The product code is LCC, regulated under 21 CFR 886.4610, in the Ophthalmic specialty. Third-party review eligibility applies.
Basic Information
- Product Code
- LCC
- Device Class
- FDA class 2
- Regulation Number
- 886.4610
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K112952 | ILWAIT TIMER OCULOPRESSOR | May 10, 2012 | Substantially Equivalent | ORYX MEDICAL PTY LTD |
| K946194 | WEE BAG O'MERCURY | Feb 27, 1995 | Substantially Equivalent | MICROSURGICAL TECHNOLOGY, INC. |
| K852032 | OCULAR PRESSURE REDUCER (MCCANNEL) | Aug 12, 1985 | Substantially Equivalent | VISITEC CO. |
| K840004 | WEE BAG O'MERCURY | Mar 22, 1984 | Substantially Equivalent | SURGI-QUIP INC.U |
| K820526 | RELIEF VALVE-HONAN INTRAOC. PRESSURE | Mar 25, 1982 | Substantially Equivalent | THE LEBANON CORP. |
| K792255 | NEVYAS AUTOPRESS EYE COMPRESSOR | Dec 11, 1979 | Substantially Equivalent | KEELER OPTICAL PRODUCTS LTD. |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.