The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for Softrans Injector.
| Device ID | K913626 |
| 510k Number | K913626 |
| Device Name: | SOFTRANS INJECTOR |
| Classification | Intraocular Lens |
| Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Contact | David S Fernquist |
| Correspondent | David S Fernquist STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Product Code | HQL |
| CFR Regulation Number | 886.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-15 |
| Decision Date | 1991-12-18 |