Specular Microscope CEM- 530— 510(k) K151706
Substantially EquivalentNidek Co., Ltd.
FDA 510(k) clearance K151706 for Specular Microscope CEM- 530, Substantially Equivalent on 2016-03-17. Applicant: Nidek Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Nidek Co., Ltd.
- Product code
- Code NQE
- Device class
- Class 2
- Regulation
- 21 CFR 886.1850
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gamagori, JP
Recent devices under product code NQE
view allMore clearances from Nidek Co., Ltd.
view allRecalls naming K151706
K-number listed on FDA's recall record- Z-0771-2020 — NIDEK Specular Microscope, Model CEM-530 - Product Usage: The device provides noncontact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images.
- Z-2711-2016 — SPECULAR MICROSCOPE CEM-530; Software version 1.08 and 1.09. Opthalmic: The NIDEK Specular Microscope CEM-530 provides non-contact, high magnification image capture of endothelium enabling observation of the size and shape of cells. Information such as the number of endothelial cells, cell density, and cell area is analyzed through the captured images. The captured images and analysis results of endothelium are used for intraocular or corneal surgery, postoperative follow-up and corneal observation such as for endothelial disorders or the corneal state of patients who wear extended-wear contact lenses.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K151706.
Data sourced from openFDA. This site is unofficial and independent of the FDA.