The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for Staaxl-3 Small Incision System Tm, Phacofragmentat.
| Device ID | K851936 |
| 510k Number | K851936 |
| Device Name: | STAAXL-3 SMALL INCISION SYSTEM TM, PHACOFRAGMENTAT |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Contact | Callahan |
| Correspondent | Callahan STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-06 |
| Decision Date | 1985-08-20 |