CENTURION Vision System (Active SentryTM)
FDA 510(k) K161794 · Alcon Research, Ltd.
510(k) numberK161794
Submission
- Device name
- CENTURION Vision System (Active SentryTM)
- Applicant
- Alcon Research, Ltd.
Fort Worth, TX, US - Received
- June 30, 2016
- Decision date
- April 14, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HQC – Unit, Phacofragmentation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4670
- Specialty
- Ophthalmic
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Questions and answers
When was CENTURION Vision System (Active SentryTM) cleared by the FDA?
CENTURION Vision System (Active SentryTM) (K161794) received a 510(k) decision of Substantially Equivalent on April 14, 2017, 288 days after the submission was received.
What is the product code of K161794?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.