The following data is part of a premarket notification filed by Suzhou 66 Vision Tech Co., Ltd. with the FDA for Yz3 Portable Slit Lamp.
| Device ID | K131711 |
| 510k Number | K131711 |
| Device Name: | YZ3 PORTABLE SLIT LAMP |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | SUZHOU 66 VISION TECH CO., LTD. NO. 34 DARU LANE Suzhou, Jiangsu, CN 215005 |
| Contact | Hongling Xia |
| Correspondent | Hongling Xia SUZHOU 66 VISION TECH CO., LTD. NO. 34 DARU LANE Suzhou, Jiangsu, CN 215005 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-11 |
| Decision Date | 2014-05-09 |