510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K864183Substantially Equivalent

Ophthalmic Surgical Instruments

Techno Ophthalmics Intl., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864183 is the FDA 510(k) clearance record for OPHTHALMIC SURGICAL INSTRUMENTS, a class I device, cleared for Techno Ophthalmics Intl. on under FDA product code HNR (Forceps, Ophthalmic). FDA records list one 510(k) clearance for Techno Ophthalmics Intl. As of , FDA records show no recalls naming K864183.

Clearance record

Decision date
Received
(32 days to decision)
Product code
HNR Forceps, Ophthalmic
Regulation
21 CFR 886.4350
Device class
Class I
Review panel
Ophthalmic
Applicant
Techno Ophthalmics Intl. 15a Marconi St., Irvine CA
Third party review
No

Clearances, product code HNR

Trailing 12 months

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

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