510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K834354Substantially Equivalent

Ophtec Rust Ring Remover

JEDMED Instrument Company, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K834354 is the FDA 510(k) clearance record for OPHTEC RUST RING REMOVER, a class I device, cleared for Jedmed Instrument Co. on under FDA product code HOG (Burr, Corneal, Battery-Powered). FDA records list 93 510(k) clearances for Jedmed Instrument Co., from to . As of , FDA records show no recalls naming K834354.

Clearance record

Decision date
Received
(97 days to decision)
Product code
HOG Burr, Corneal, Battery-Powered
Regulation
21 CFR 886.4070
Device class
Class I
Review panel
Ophthalmic
Applicant
Jedmed Instrument Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HOG

Trailing 12 months

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

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