The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for Elastic Lens Injector Tm.
| Device ID | K861085 |
| 510k Number | K861085 |
| Device Name: | ELASTIC LENS INJECTOR TM |
| Classification | Lens, Guide, Intraocular |
| Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Contact | Robert W Callahan |
| Correspondent | Robert W Callahan STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Product Code | KYB |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-03-21 |
| Decision Date | 1986-05-28 |