510(k) K130565
- Device
- SPECULAR MICROSCOPE CEM-530
- Applicant
- NIDEK CO., LTD.
- 510(k) number
- K130565
- Product code
- NQE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2013-11-27
- Date received
- 2013-03-04
- Regulation
- 886.1850
- Classification name
- Microscope, Specular
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Aron Shapiro
- Address
- 300 Brickstone Sq. Andover MA US 01810 01810
FDA Registration Numbers#
- 9680854
- 3008729548
- 3008717264
- 3002807715
- 9614661
- 1054713
- 8030392
- 2936921
Source Documents#
Other 510(k) Records For Product Code NQE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191558 | Konan Specular Microscope XVII | Konan Medical, Inc. | 2020-03-26 |
| K173980 | Specular Microscope CEM-530 | Nidek Co., Ltd. | 2018-03-14 |
| K171313 | EM-4000 Specular Microscope | Tomey Corporation | 2018-01-19 |
| K151706 | Specular Microscope CEM- 530 | Nidek Co., Ltd. | 2016-03-17 |
| K142417 | SP-1PSpecular Microscope | Topcon Corporation | 2015-05-29 |
| K120264 | KONAN SPECULAR MICROSCOPE XIV | Konan Medical, Inc. | 2012-04-11 |
| K062763 | NONCON ROBO PACHY F&A | Konan Medical, Inc. | 2008-02-22 |
| K040373 | KERATO ANALYZER (EKA) | Konan Medical, Inc. | 2004-03-19 |
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases