OCULAB TONOPEN
Device Facts
| Record ID | K852774 |
|---|---|
| Device Name | OCULAB TONOPEN |
| Applicant | Oculab, Inc. |
| Product Code | HKY · Ophthalmic |
| Decision Date | Aug 20, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1930 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.
