510(k) K143275
- Device
- IOLMaster700
- Applicant
- Carl Zeiss Meditec, Inc.
- 510(k) number
- K143275
- Product code
- HJO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-07-10
- Date received
- 2014-11-14
- Regulation
- 886.1850
- Classification name
- Biomicroscope, Slit-lamp, Ac-powered
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Christine Dunbar
- Address
- 5160 Hacienda Dr. Dublin CA US 94568 94568
FDA Registration Numbers#
- 1000176188
- 2027009
- 3011442035
- 3002807715
- 1926681
- 3003144120
- 3009173773
- 3005527296
- 1226587
- 3038356864
- 9612297
- 1054713
- 3004095901
- 3005771344
- 1319721
- 3015316279
- 1937310
- 9710516
- 3005785090
- 3010675798
- 2080939
- 3007913988
- 3004438257
- 3011223751
- 9615030
- 3011898560
- 9611269
- 3013403214
- 8030392
- 3008169506
- 2952604
- 2939653
- 3015972897
- 3008729548
- 9614661
- 3005755367
- 2918630
- 3010610157
- 3009746052
- 3010227033
- 3010202439
- 3003553186
- 2936921
- 9617474
- 9616199
- 2521877
- 1000391004
- 8020986
- 2020550
- 3020723591
- 3014342096
- 9615010
- 3033566
- 3012423824
- 3004441848
Source Documents#
Other 510(k) Records For Product Code HJO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253834 | VISUREF 600 | Carl Zeiss Vision GmbH | 2026-03-18 |
| K231760 | HP-OCT (HP-OCT) | Cylite Pty. , Ltd. | 2024-03-08 |
| K222372 | Kowa SL-19 | Kowa Company , Ltd. | 2022-11-21 |
| K193188 | MiiS Horus Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2020-01-14 |
| K182306 | Sunkingdom Slit Lamp | Chongqing Sunkingdom Medical Instrument Co., Ltd. | 2018-11-22 |
| K173771 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2018-08-24 |
| K171877 | SLM-1ER, SLM-2ER, SLM-3ER | Chongqing Kanghua Ruiming S&T Co., Ltd. | 2017-12-21 |
| K170470 | Digital Eye Anterior Camera | Medimaging Integrated Solution, Inc (Miis) | 2017-10-06 |
| K162778 | Portable Slit Lamp Microscope | Suzhou Kangjie Medical, Inc. | 2017-07-21 |
| K162684 | SL 220 | Carl Zeiss Meditec, AG | 2017-05-31 |
| K163564 | SLIT LAMP SL-2000 | Nidek Co., Ltd. | 2017-05-19 |
| K162636 | Marco Ultra M3, Marco Ultra M4 | Takagi Seiko Co., Ltd. | 2017-04-14 |
| K170171 | IOLMaster 700 | Carl Zeiss Meditec, AG | 2017-04-06 |
| K161607 | VISULUX | Carl Zeiss Meditec, AG | 2017-02-23 |
| K161764 | SLIT LAMP, Model: YF-100 | Chongqing Yeasn Science-Technology Co., Ltd. | 2017-02-16 |
Legacy Summary#
summary
FDA Review#
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