510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K881334Substantially Equivalent

Light Coagulator Lc 250

Nk-Optik GmbH, Munich D8000, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K881334 is the FDA 510(k) clearance record for LIGHT COAGULATOR LC 250, a class II device, cleared for Nk-Optik GmbH on under FDA product code HAM (Apparatus, Electrosurgical). FDA records list one 510(k) clearance for Nk-Optik GmbH. As of , FDA records show no recalls naming K881334.

Clearance record

Decision date
Received
(596 days to decision)
Product code
HAM Apparatus, Electrosurgical
Regulation
21 CFR 878.4400
Device class
Class II
Review panel
General, Plastic Surgery
Applicant
Nk-Optik GmbH Forstenrieder Allee 221, Munich D8000, DE
Third party review
No

Clearances, product code HAM

Trailing 12 months

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

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