Submission Details
| 510(k) Number | K141065 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 24, 2014 |
| Decision Date | August 22, 2014 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
CONSTELLATION VISION SYSTEM
Aug 2014
Decision
120d
Days
Class 2
Risk
About This 510(k) Submission
K141065 is an FDA 510(k) clearance for the CONSTELLATION VISION SYSTEM, a Instrument, Vitreous Aspiration And Cutting, Ac-powered (Class II — Special Controls, product code HQE), submitted by Alcon Research, Ltd. (Lake Forest, US). The FDA issued a Cleared decision on August 22, 2014, 120 days after receiving the submission on April 24, 2014. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.4150.
Device Classification
| Product Code | HQE — Instrument, Vitreous Aspiration And Cutting, Ac-powered |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.4150 |
Manufacturer
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