510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830871Substantially Equivalent

Phakosystems Model 1000/Omni Packs Irrigation/aspiration

Phakosystems, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830871 is the FDA 510(k) clearance record for PHAKOSYSTEMS MODEL 1000/OMNI PACKS IRRIGATION/ASPIRATION, a class I device, cleared for Phakosystems, Inc. on under FDA product code HOC (Clip, Iris Retractor). FDA records list 5 510(k) clearances for Phakosystems, Inc., from to . As of , FDA records show no recalls naming K830871.

Clearance record

Decision date
Received
(76 days to decision)
Product code
HOC Clip, Iris Retractor
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Phakosystems, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HOC

Trailing 12 months

FDA records hold no clearances under product code HOC in the trailing twelve months.

FDA records show no clearances under product code HOC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HOC, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260