The following data is part of a premarket notification filed by Lenstec Inc. with the FDA for Lenstec Lc Injection System.
| Device ID | K161776 |
| 510k Number | K161776 |
| Device Name: | Lenstec LC Injection System |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | LENSTEC INC. 1765 COMMERCE AVE.N. St. Petersburg, FL 33716 |
| Contact | Jimmy Chacko |
| Correspondent | Jimmy Chacko LENSTEC INC. 1765 COMMERCE AVE.N. St. Petersburg, FL 33716 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-29 |
| Decision Date | 2016-11-29 |
| Summary: | summary |