510(k) K112952
K112952 is an FDA 510(k) premarket notification submitted by Oryx Medical Pty, Ltd. for the device "ILWAIT TIMER OCULOPRESSOR". The FDA issued a decision of Substantially Equivalent on May 10, 2012. The device falls under product code LCC (Applicator, Ocular Pressure), a Class II device regulated under 21 CFR 886.4610.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2012
- Date Received
- October 5, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Applicator, Ocular Pressure
- Device Class
- Class II
- Regulation Number
- 886.4610
- Review Panel
- OP
- Submission Type