510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K833642Substantially Equivalent

Phako Systems via 2000

Pharosystems, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833642 is the FDA 510(k) clearance record for PHAKO SYSTEMS VIA 2000, a class II device, cleared for Pharosystems, Inc. on under FDA product code HQC (Unit, Phacofragmentation). FDA records list one 510(k) clearance for Pharosystems, Inc. As of , FDA records show no recalls naming K833642.

Clearance record

Decision date
Received
(140 days to decision)
Product code
HQC Unit, Phacofragmentation
Regulation
21 CFR 886.4670
Device class
Class II
Review panel
Ophthalmic
Applicant
Pharosystems, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HQC

Trailing 12 months
3 clearances under product code HQC in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQC, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20260
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260