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Lutronic CLARITY II Laser System
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MEDICAL DEVICE RECALLMODERATE

Lutronic CLARITY II Laser System

Lutronic is recalling CLARITY II Laser System (Model 1110200210) due to sparking and burn hazard.

What to do

Stop using the device immediately. Contact Lutronic Corporation for instructions on device return or repair.

Recalled
Listed
Updated
Recall No.
Z-1558-2026
Agency
FDA
Firm
Lutronic Corporation
Recall ID
98372
Status
ONGOING

Recall at a glance

Quantity recalled
1,525 units

Why it was recalled

Lutronic Corporation is recalling the CLARITY II Laser System, Model No. 1110200210, worldwide due to reports of the device sparking, popping, and potentially burning patients during use.

Is mine affected?

Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.

CLARITY II Laser System; Model No. 1110200210.

UDI-DI
1110200210, 08809447653723

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Official source

View on U.S. Food and Drug Administration →

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Editorial summary by Recall Canary · summary updated 2026-04-27 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification