KYD · Strip, Schirmer
Ophthalmic · 21 CFR 886.1800 · Class 1
Overview
| Product Code | KYD |
|---|---|
| Device Name | Strip, Schirmer |
| Regulation | 21 CFR 886.1800 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A Schirmer strip is a device made of filter paper or similar material intended to be inserted under a patient's lower eyelid to stimulate and evaluate formation of tears.
Classification Rationale
Class I (general controls). If the device is made of the same materials that were used in the device before May 28, 1976, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9.
Recent Cleared Devices (3 of 3)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K911734 | TEARTEC RAPID LACRIMAL ASSESMENT SYSTEM | Northland Cataract & Eye Care Clinic | Nov 7, 1991 | SESE |
| K881515 | TEAR VOLUME TESTS | Visionex, Inc. | May 23, 1988 | SESE |
| K832181 | SNO STRIPS STERILE TEARFLOW TEST STRIP | Smith & Nephew, Inc. | Aug 12, 1983 | SESE |
Top Applicants
- Northland Cataract & Eye Care Clinic — 1 clearance
- Smith & Nephew, Inc. — 1 clearance
- Visionex, Inc. — 1 clearance
