Infiniti Vision System with Ozil Ip
FDA 510(k) K082845 · Alcon Research, Ltd.
510(k) numberK082845
Submission
- Device name
- Infiniti Vision System with Ozil Ip
- Applicant
- Alcon Research, Ltd.
Fort Worth, TX, US - Received
- September 26, 2008
- Decision date
- February 12, 2009
- 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 Infiniti Vision System with Ozil Ip cleared by the FDA?
Infiniti Vision System with Ozil Ip (K082845) received a 510(k) decision of Substantially Equivalent on February 12, 2009, 139 days after the submission was received.
What is the product code of K082845?
The FDA product code is HQC – Unit, Phacofragmentation, a Class II (moderate risk) device regulated under 21 CFR 886.4670.