510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K964380Substantially Equivalent

Lc-250 Infrared Light Coagulator

Nk-Optik America, Chicago IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964380 is the FDA 510(k) clearance record for LC-250 INFRARED LIGHT COAGULATOR, a class II device, cleared for Nk-Optik America on under FDA product code HQB (Photocoagulator And Accessories). FDA records list one 510(k) clearance for Nk-Optik America. As of , FDA records show no recalls naming K964380.

Clearance record

Decision date
Received
(79 days to decision)
Product code
HQB Photocoagulator And Accessories
Regulation
21 CFR 886.4690
Device class
Class II
Review panel
Ophthalmic
Applicant
Nk-Optik America 1819 S. May St., 2f, Chicago IL
510(k) summary
Statement
Third party review
No

Clearances, product code HQB

Trailing 12 months

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

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