510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K082845Substantially Equivalent

Infiniti Vision System with Ozil Ip

Alcon Laboratories, Fort Worth TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082845 is the FDA 510(k) clearance record for INFINITI VISION SYSTEM WITH OZIL IP, a class II device, cleared for Alcon Research, Ltd. on under FDA product code HQC (Unit, Phacofragmentation). FDA records list 152 510(k) clearances for Alcon Laboratories, from to . As of , FDA records show no recalls naming K082845.

Clearance record

Decision date
Received
(139 days to decision)
Product code
HQC Unit, Phacofragmentation
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
Alcon Research, Ltd. 6201 S. Fwy., Fort Worth TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HQC

Trailing 12 months
3 clearances under product code HQC in the twelve months to November 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQC, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20261
November 20260