Use cautionMedical device recall · FDA · Published January 27, 2026
Lutronic CLARITY II Laser System Model 1110200210 Sparks and May Burn Patients
Lutronic recalls CLARITY II Laser System model 1110200210 due to reports of sparking and potential patient burns. Affected units have specific serial numbers listed in the recall notice.
“Lutronic CLARITY II Laser System Model 1110200210 Sparks and May Burn Patients.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/50090-lutronic-clarity-ii-laser-system-model-1110200210-sparks-and-may. Based on FDA recall #Z-1558-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1558-2026%22&limit=1).
The FDA announced on Jan. 27, 2026, that Lutronic Corporation is recalling its CLARITY II Laser System due to reports of devices sparking or popping and potentially burning patients. Owners should contact the company for a remedy.
How to tell if you have it
Brand: Lutronic
Product: CLARITY II Laser System
Model No.: 1110200210
UDI: 08809447653723
Units affected: 1,525
The hazard
According to the FDA, reports indicate that the CLARITY II Laser System devices may spark or pop, potentially causing patient burns.
Context
GovInfoNow's records show Lutronic Corporation has two other recalls on record since Sept. 4, 2025. On Aug. 6, 2026, the company recalled the DermaV Laser System due to a risk of patient burn during treatment. Other recent recalls of similar products include the Olympus SOLTIVE Pro Laser System recall (Feb. 27, 2026), the Olympus SOLTIVE Laser System recall (Feb. 27, 2026), and the Diowave Laser System recall (Jan. 9, 2026).
How to tell if you have this one
Check for the model number 1110200210 on the device. Affected units have specific serial numbers listed in the recall notice, including many starting with 'C30' followed by numbers.
Brand
Lutronic
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Stop Using It Now
If you have the recalled model, stop using it immediately to prevent potential burns.
Where it went and when
Where it was distributed
Distributed nationwide, and outside the U.S.
Nationwide
Not listed
FDA distribution: “Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide, and outside the U.S.
Recall timeline
FDA published this recall 50 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-1558-2026 (January 27, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1558-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.