Reported Mar 18, 2026 · Ongoing

CLARITY II Laser System; Model No. 1110200210.

Lutronic Corporation

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Lutronic Corporation · 219 Sowon-Ro; Deogyang · Goyang, N/A · N/A

Is this the product you have?

  • CLARITY II Laser System; Model No. 1110200210.
Lot codes and dates
  • Model No. 1110200210
  • UDI

    1,057 of 1,057 codes

    • 08809447653723
    • Serial No. C3023K024
    • C3022B006
    • C3025D028
    • C3022L031
    • C3024D027
    • C3022H015
    • C3024K033
    • C3019J018
    • C3024K030
    • C3025B076
    • C3023K043
    • C3021K002
    • C3025E050
    • C3025E035
    • C3022L010
    • C3023G009
    • C3023J037
    • C3021D021
    • C3020C010
    • C3019L007
    • C3025B011
    • C3025B012
    • C3022G011
    • C3022F020
    • C3025D076
    • C3024J038
    • C3025E041
    • C3021L005
    • C3025C022
    • C3024G026
    • C3023B044
    • C3021F012
    • C3024G008
    • C3024D025
    • C3025E065
    • C3024F030
    • C3022H021
    • C3022H022
    • C3025C029
    • C3023L034
    • C3023L070
    • C3023D060
    • C3024H029
    • C3025D094
    • C3023L043
    • C3022M010
    • C3023C008
    • C3025D085
    • C3022J035
    • C3022K009
    • C3023K035
    • C3025B071
    • C3021F001
    • C3023J006
    • C3022L026
    • C3022J033
    • C3023J004
    • C3024G004
    • C3022D023
Amount recalled
1,525 units

Where it was sold

  • Nationwide

Why it was recalled

Reports of devices sparking/popping and potentially burning patients.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Lutronic Corporation recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 4:13 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.