The following data is part of a premarket notification filed by Alcon Research, Ltd. with the FDA for Constellation Vision System.
| Device ID | K141065 |
| 510k Number | K141065 |
| Device Name: | CONSTELLATION VISION SYSTEM |
| Classification | Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Applicant | ALCON RESEARCH, LTD. 20511 Lake Forest Dr Lake Forest, CA 92630 |
| Contact | Robert Lundberg |
| Correspondent | Robert Lundberg ALCON RESEARCH, LTD. 20511 Lake Forest Dr Lake Forest, CA 92630 |
| Product Code | HQE |
| CFR Regulation Number | 886.4150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-24 |
| Decision Date | 2014-08-22 |
| Summary: | summary |