Recall Z-1558-2026— Lutronic Corporation

Name: FDA recall Z-1558-2026
Creator: U.S. Food and Drug Administration
Published: 2026-01-27

Class II · Ongoing

Class II FDA medical device recall by Lutronic Corporation, initiated 2026-01-27. It names one FDA 510(k) clearance: K183566. Product: CLARITY II Laser System; Model No. 1110200210.. Reason: Reports of devices sparking/popping and potentially burning patients..

Recalling firm: Lutronic Corporation
Classification: Class II
Status: Ongoing
Initiated: 2026-01-27
Firm location: Goyang, N/A, Korea (the Republic of)

510(k) clearances named in this recall

1 on FDA's record

K183566 — CLARITY II Laser SystemLutronic Corporation·cleared 2019-06-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

CLARITY II Laser System; Model No. 1110200210.

Reason for recall

Reports of devices sparking/popping and potentially burning patients.

Data sourced from openFDA. This site is unofficial and independent of the FDA.