Insight Instruments, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 3
- 510(k) Clearances
- 1
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0144-2014 | Class II | MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for | June 27, 2013 |
| D-1056-2014 | Class II | Cornea Coat, Hydroxypropylmethylcellulose, 1.5ml Syringe, Rx Only. Manufactured by: Insight Instrum | April 24, 2013 |
| Z-1281-2013 | Class II | Insight Instruments MIS ( Multi-Port Illumination System) Illuminated pilot tubes work like a c | March 15, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K051630 | SUPER VIEW DISPOSABLE BIOM LENS SET | June 29, 2005 |