Biomicroscope, Slit-lamp, Ac-powered, Exempt
Ophthalmic · 21 CFR 886.1850
This product code is the class II exempt counterpart of HJO, and was exempted, subject to the limitations of exemption, under the procedures established by the 21st Century Cures Act. This device type does not require premarket notification (510(k)) to market if it does not exceed the general limitations of exemption found in 21 CFR 886.9 and the specific limitations of exemption as stated in the Physical State field of this product code description.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
31 firms currently registered for this product code
Lianyungang Tiannuo Optical Instrument Co., Ltd.
LIANYUNGANG Jiangsu, CN
Remidio Innovative Solutions Private Limited
Bengaluru Karnataka, IN
Shanghai Mediworks Precision Instruments Co., Ltd.
Shanghai, CN
Frey Spolka Jawna
PIASECZNO Mazowieckie, PL
Beijing Hongdee Corporation
Beijing, CN
Chongqing Sunkingdom Medical Instrument Co.,ltd
Chongqing, CN
Lightfield Medical, Inc.
Minneapolis, MN, US
Lightfield Medical Europe, S.l.u.
Viladecans Barcelona, ES
Ray Vision Inc.
Lake Forest, CA, US
Shenzhen Certainn Technology Co., Ltd.
Shenzhen Guangdong, CN
Apramed Usa Llc
Kissimmee, FL, US
Shanghai Bolan Optical Electric Co., Ltd
Shanghai, CN
Visuscience Meditech Co., Ltd.
WUXI Jiangsu, CN
Takagi Seiko Co., Ltd.
NAKANO-SHI Nagano, JP
Toyo Medical Co.
Doral, FL, US
Zumax Medical Co, Ltd.
SUZHOU,JIANGSU, CN
Taizhou City K&w International Trade Co.,ltd.
Jiangyan Jiangsu, CN
Forus Health Pvt.ltd.,
Bengaluru Karnataka, IN
Haag-streit Ag
KOENIZ Bern, CH
Eyoto Group Limited
Birmingham, GB
Towa Medical Instruments Co.,ltd.
Nakano-shi Nagano, JP
Gaush Neotech Ltd.
Wuxi Jiangsu, CN
Main Meditech Co., Ltd
Chongqing, CN
Mark Enterprises
Nashik Maharashtra, IN
Labotech Microscopes India Private Limited
AMBALA CANTT Haryana, IN
510(k) clearances
0 clearances for this product code
No 510(k) clearances on file for this product code.