NQE · Microscope, Specular
Ophthalmic · 21 CFR 886.1850 · Class 2
Overview
| Product Code | NQE |
|---|---|
| Device Name | Microscope, Specular |
| Regulation | 21 CFR 886.1850 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
| 3rd-Party Reviewable | Yes |
Identification
An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.
Classification Rationale
Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, 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 (9 of 9)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K191558 | Konan Specular Microscope XVII | Konan Medical, Inc. | Mar 26, 2020 | SESE |
| K173980 | Specular Microscope CEM-530 | Nidek Co., Ltd. | Mar 14, 2018 | SESE |
| K171313 | EM-4000 Specular Microscope | Tomey Corporation | Jan 19, 2018 | SESE |
| K151706 | Specular Microscope CEM- 530 | Nidek Co., Ltd. | Mar 17, 2016 | SESE |
| K142417 | SP-1PSpecular Microscope | Topcon Corporation | May 29, 2015 | SESE |
| K130565 | SPECULAR MICROSCOPE CEM-530 | Nidek Co., Ltd. | Nov 27, 2013 | SESE |
| K120264 | KONAN SPECULAR MICROSCOPE XIV | Konan Medical, Inc. | Apr 11, 2012 | SESE |
| K062763 | NONCON ROBO PACHY F&A | Konan Medical, Inc. | Feb 22, 2008 | SESE |
| K040373 | KERATO ANALYZER (EKA) | Konan Medical, Inc. | Mar 19, 2004 | SESE |
Top Applicants
- Konan Medical, Inc. — 4 clearances
- Nidek Co., Ltd. — 3 clearances
- Tomey Corporation — 1 clearance
- Topcon Corporation — 1 clearance
