PLZ — Ocular Pattern Recorder Class II
FDA product code PLZ covers "Ocular Pattern Recorder", a Class II medical device regulated under 21 CFR 886.1925. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- PLZ
- Device Class
- Class II
- Regulation Number
- 886.1925
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
A diurnal pattern recorder system is a non-implantable, prescription device incorporating a telemetric sensor intended to detect changes in ocular dimension for monitoring diurnal patterns of IOP fluctuation.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN140017 | sensimed | SENSIMED TRIGGERFISH | March 4, 2016 |