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RecallWatchMedical Device Safety
Class IIOngoingZ-1558-2026

Lutronic Corporation recalls CLARITY II Laser System

Lutronic CorporationGoyang, Korea (the Republic of)Reported Mar 18, 2026 · 5 months ago
Legal News Analyst ·

Reason for recall

Reports of devices sparking/popping and potentially burning patients.

Affected product

Check your device

Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.

CLARITY II Laser System; Model No. 1110200210.

Lot / code information

Model
1110200210
UDI
08809447653723
Serial #
C3023K024, C3022B006, C3025D028, C3022L031, C3024D027, C3022H015 — +1050 moreShow all
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, C3025E028, C3021L031, C3023K048, C3025D080, C3019M006, C3022A003, C3023K027, C3021K020, C3022K023, C3025D035, C3023J029, C3022E030, C3021L007, C3025B078, C3023J041, C3023A020, C3025E038, C3023H019, C3025C034, C3024J041, C3025E047, C3025D097, C3022E026, C3024J089, C3025B033, C3023B002, C3023B040, C3023B018, C3022K007, C3024F012, C3022G015, C3022J024, C3025B118, C3024J088, C3023L010, C3022F014, C3022F015, C3024J078, C3023L041, C3020K009, C3019J007, C3020K012, C3023B035, C3024J046, C3025D040, C3024J047, C3020J012, C3024J091, C3025D039, C3024M058, C3020L006, C3023E026, C3023E027, C3022K020, C3023L027, C3020L008, C3022L040, C3024G014, C3023M020, C3025E091, C3022A032, C3022B012, C3025E095, C3025C019, C3025C020, C3025C017, C3025C018, C3024D002, C3024C017, C3022J011, C3020H003, C3023H016, C3024C013, C3022A009, C3022J030, C3021F013, C3023E029, C3021M005, C3025E027, C3022K008, C3023K046, C3023D015, C3024G022, C3025B003, C3025E073, C3023L012, C3024H016, C3024J043, C3021G022, C3019K005, C3023G031, C3023E037, C3025E033, C3023M024, C3025D105, C3023F021, C3025E060, C3024F013, C3022E029, C3024K051, C3024J086, C3025C035, C3023E024, C3024J045, C3023J042, C3025B028, C3023F025, C3023L035, C3023C013, C3023D049, C3023D048, C3021J003, C3023F015, C3025E034, C3023A019, C3020G002, C3023D041, C3023D045, C3025D099, C3023G013, C3023D018, C3024M055, C3023C012, C3023F022, C3025C026, C3022L038, C3024H031, C302J009, C3025E032, C3024K117, C3022K006, C3024G017, C3024J049, C3022F001, C3023J017, C3022J027, C3021A007, C3023A024, C3024H077, C3024K016, C3025B079, C3023D002, C3022A033, C3023F020, C3023F019, C3022L036, C3023M021, C3024G018, C3025D084, C3025E006, C3024H021, C3024J036, C3022H013, C3025B118, C3024M060, C3024J075, C3022F019, C3019M009, C3019K003, C3023L039, C3024H016, C3022M016, C3024K113, C3022J028, C3022L056, C3022H014, C3022C011, C3021K004, C3024H079, C3025B074, C3024K054, C3023K031, C3022H020, C3024H074, C3023K030, C3022B005, C3025D081, C3024G010, C3025E056, C3021D018, C3021L030, C3025E025, C3019M001, C3021J001, C3021M018, C3022K019, C3021L008, C3021G020, C3019K009, C3023E035, C3022J029, C3021A008, C3025D102, C3024K114, C3022E020, C3020L003, C3023L044, C3024J042, C3023E038, C3023L068, C3022M004, C3023E040, C3024D031, C3019M007, C3023K042, C3024J054, C3024K023, C3023C016, C3023C020, C3024K035, C3022A007, C3023D044, C3023B005, C3022C009, C3024J081, C3023L069, C3022L003, C3024H028, C3019K004, C3025D030, C3024H061, C3024C018, C3025E011, C3025E052, C3021M007, C3025E075, C3025D083, C3025E054, C3020C007, C3025D101, C3024J044, C3024H030, C3025D043, C3023J036, C3025B072, C3025D082, C3023H017, C3024D028, C3023D014, C3022F010, C3023A026, C3025D096, C3023L037, C3024E007, C3025B115, C3024K111, C3023J005, C3025B113, C3023J039, C3023J011, C3023D021, C3019K008, C3024H015, C3024J090, C3023E023, C3023D059, C3023K022, C3022F005, C3024H041, C3023C018, C3023A022, C3023L033, C3025B073, C3025D095, C3022L033, C3023J014, C3022J025, C3019L004, C3025B009, C3025E051, C3020G003, C3024E009, C3024H014, C3022F021, C3025B111, C3022J002, C3022L041, C3021K021, C3025E023, C3025E071, C3022L049, C3024C019, C3023L019, C3023K049, C3023C010, C3020J005, C3021M011, C3021K003, C3023H014, C3022M006, C3023A021, C3021M010, C3025E029, C3023D012, C3020G008, C3024G024, C3025D103, C3024D023, C3023L073, C3022D025, C3024H034, C3023C006, C3022L039, C3024K116, C3024H024, C3021D017, C3023B004, C3024H071, C3021J033, C3022H025, C3024H033, C3021H017, C3025D098, C3023K034, C3023G025, C3024J003, C3024K020, C3019M008, C3025B037, C3025B036, C3022E016, C3022M009, C3025E049, C3023G026, C3023D008, C3024F011, C3025E039, C3022F012, C3023B041, C3024K057, C3025D065, C3024H075, C3023B042, C3024D026, C3021F011, C3024J035, C3024K021, C3021F008, C3023L014, C3024H020, C3023G016, C3020G009, C3024E005, C3025D061, C3022L057, C3020J013, C2014K002, C3023E041, C3025E074, C3025D045, C3025D086, C3024K022, C3025E036, C3025D027, C3023C017, C3022A002, C3025D036, C3023D016, C3023F016, C3024G016, C3025E076, C3025B119, C3023K044, C3022L018, C3024H040, C3024K027, C3019L001, C3025E013, C3020J004, C3023B010, C3022E014, C3022J008, C3022E017, C3022A034, C3023J034, C3024K034, C3024H068, C3023J043, C3023L076, C3022H024, C3025C031, C3023A028, C3019J010, C3022J015, C3023D043, C3023D050, C3023B016, C3022L006, C3022L005, C3025E062, C3023G024, C3023K041, C3022K010, C3023H015, C3025D100, C3025B034, C3025B031, C3022G014, C3025E066, C3025E014, C3025C016, C3023G010, C3022L042, C3022L043, C3022L044, C3023L071, C3023G029, C3023L007, C3025E044, C3020L001, C3021M004, C3024C012, C3025D029, C3022L028, C3022L035, C3025E063, C3025E048, C3022H018, C3022H019, C3022K013, C3021F010, C3020J014, C3020K011, C3022M007, C3021D016, C3025E093, C3022M008, C3024D030, C3025D063, C3023E042, C3022E028, C3025D037, C3022L007, C3025E021, C3024K050, C3023K047, C3025E017, C3022M014, C3023K036, C3023K050, C3023J002, C3024F027, C3025C028, C3022A035, C3025E072, C3024K120, C3024H067, C3024H064, C3024H063, C3024H065, C3022C029, C3025E019, C3024K025, C3022J014, C3022L027, C3022F006, C3023A023, C3022A031, C3022D024, C3025E094, C3020J008, C3019H008, C3024H070, C3024H060, C3021D022, C3024J084, C3024J075, C3025D042, C3024K119, C3025E089, C3019H002, C3019J017, C3023B017, C3022L009, C3025E030, C3023H020, C3022M005, C3022K014, C3025E064, C3022A028, C3024H037, C3019L002, C3024H072, C3022H016, C3024G005, C3020L002, C3024J …
DistributionShow details

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

Class IIWhat this means

Use of the product may cause temporary or medically reversible adverse health consequences.

Sources & references

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.

Taylor Coteus
Legal News Analyst

Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.

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