HJO — Biomicroscope, Slit-Lamp, Ac-Powered Class II
FDA product code HJO covers "Biomicroscope, Slit-Lamp, Ac-Powered", a Class II medical device regulated under 21 CFR 886.1850. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- HJO
- Device Class
- Class II
- Regulation Number
- 886.1850
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253834 | carl zeiss vision | VISUREF 600 | March 18, 2026 |
| K231760 | cylite pty. | HP-OCT (HP-OCT) | March 8, 2024 |
| K222372 | kowa company | Kowa SL-19 | November 21, 2022 |
| K193188 | medimaging integrated solution, inc (miis) | MiiS Horus Eye Anterior Camera | January 14, 2020 |
| K182306 | chongqing sunkingdom medical instrument co | Sunkingdom Slit Lamp | November 22, 2018 |
| K173771 | carl zeiss meditec | IOLMaster 700 | August 24, 2018 |
| K171877 | chongqing kanghua ruiming s and t co | SLM-1ER, SLM-2ER, SLM-3ER | December 21, 2017 |
| K170470 | medimaging integrated solution, inc (miis) | Digital Eye Anterior Camera | October 6, 2017 |
| K162778 | suzhou kangjie medical | Portable Slit Lamp Microscope | July 21, 2017 |
| K162684 | carl zeiss meditec | SL 220 | May 31, 2017 |
| K163564 | nidek co | SLIT LAMP SL-2000 | May 19, 2017 |
| K162636 | takagi seiko co | Marco Ultra M3, Marco Ultra M4 | April 14, 2017 |
| K170171 | carl zeiss meditec | IOLMaster 700 | April 6, 2017 |
| K161607 | carl zeiss meditec | VISULUX | February 23, 2017 |
| K161764 | chongqing yeasn science-technology co | SLIT LAMP, Model: YF-100 | February 16, 2017 |
| K161972 | topcon corporation | Slit Lamp SL-D301 | December 9, 2016 |
| K160327 | visia imaging | ALADDIN HW3.0 | October 5, 2016 |
| K153545 | shanghai bolan optical-electric co | Portable Slit Lamp | June 22, 2016 |
| K152535 | takagi seiko co | Z5 Slit lamp microscope, Z2 Slit lamp microscope | May 26, 2016 |
| K152429 | shanghai mediworks precision instruments co. | Slit Lamp Microscope | May 11, 2016 |