510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802927Substantially Equivalent

Sebestyen Irrigating Contact Lens

Cooper Medical Devices Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802927 is the FDA 510(k) clearance record for SEBESTYEN IRRIGATING CONTACT LENS, a class I device, cleared for Cooper Medical Devices Corp. on under FDA product code HJI (Lens, Fundus, Hruby, Diagnostic). FDA records list 7 510(k) clearances for Cooper Medical Devices Corp., from to . As of , FDA records show no recalls naming K802927.

Clearance record

Decision date
Received
(78 days to decision)
Product code
HJI Lens, Fundus, Hruby, Diagnostic
Regulation
21 CFR 886.1395
Device class
Class I
Review panel
Ophthalmic
Applicant
Cooper Medical Devices Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HJI

Trailing 12 months

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

FDA records show no clearances under product code HJI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HJI, 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