Product code NQE— Ophthalmic
EM-4000 Specular Microscope
- Classification name
- Microscope, Specular
- Device class
- Class 2
- Regulation
- 21 CFR 886.1850
- Advisory panel
- Ophthalmic
- Total cleared
- 9
- First cleared
- Most recent
FDA classification definition
“Specular microscopes are used for the microscopic imaging and assessment of the corneal endothelial cell layer in vivo or in vitro.”
Market context for product code NQE
FDA has cleared devices under product code NQE between 2004 and 2020, filed by 4 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2020
- 2018
- 2016
- 2015
- 2013
- 2012
- 2008
- 2004
Top applicants under product code NQE
Recent clearances under product code NQE
- K191558 — Konan Specular Microscope XVII
- K173980 — Specular Microscope CEM-530
- K171313 — EM-4000 Specular Microscope
- K151706 — Specular Microscope CEM- 530
- K142417 — SP-1PSpecular Microscope
- K130565 — SPECULAR MICROSCOPE CEM-530
- K120264 — KONAN SPECULAR MICROSCOPE XIV
- K062763 — NONCON ROBO PACHY F&A
- K040373 — KERATO ANALYZER (EKA)
Data sourced from openFDA. This site is unofficial and independent of the FDA.