510(k) K142417
- Device
- SP-1PSpecular Microscope
- Applicant
- TOPCON CORPORATION
- 510(k) number
- K142417
- Product code
- NQE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-05-29
- Date received
- 2014-08-28
- 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
- Michael Gusel
- Address
- 75-1 Hasunuma-Cho Itabashi-Ku Tokyo JP 174-8580 174-8580
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 |
| K130565 | SPECULAR MICROSCOPE CEM-530 | Nidek Co., Ltd. | 2013-11-27 |
| 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#
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