HJC · Esthesiometer, Ocular
Ophthalmic · 21 CFR 886.1040 · Class 1
Overview
| Product Code | HJC |
|---|---|
| Device Name | Esthesiometer, Ocular |
| Regulation | 21 CFR 886.1040 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
An ocular esthesiometer is a device, such as a single-hair brush, intended to touch the cornea to assess corneal sensitivity.
Classification Rationale
Class I (general controls). 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 (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K920271 | WEINSTEIN CORNEAL MIRCOAESTHESIOMETER | Connecticut Bioinstruments, Inc. | Apr 21, 1992 | SESE |
| K851557 | ANESTHESIOMETER | Luneau SA | May 30, 1985 | SESE |
Top Applicants
- Luneau SA — 1 clearance
- Connecticut Bioinstruments, Inc. — 1 clearance
