Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

CLARITY II Laser System; Model No. 1110200210.

FDA Recall Z-1558-2026 · Posted 2026-03-12

Recalling FirmLutronic Corporation
Recall StatusOpen, Classified
Product CodeGEX
Date Initiated2026-01-27
Product Quantity1,525 units

Reason for Recall

Reports of devices sparking/popping and potentially burning patients.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K183566CLARITY II Laser SystemLutronic Corporation · 2019-06-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑