Recall archive / FDA device enforcement

CLARITY II Laser System; Model No. 1110200210. — FDA record Z-1558-2026

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jan 27, 2026. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: CLARITY II Laser System; Model No. 1110200210.
Reason: Reports of devices sparking/popping and potentially burning patients.
Classification: Class II
Recalling firm: Lutronic Corporation
Quantity: 1,525 units
Agency-reported status: Ongoing
Source record identifier: Z-1558-2026

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Model No. 1110200210; UDI: 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, C3025E028, C3021L031, C3023K048, C3025D080, C3019M006, C3022A003, C3023K027, C3021K020, C3022K023, C3025D035, C3023J029, C3022E030, C3021L007, C3025B078, C3023J041, C3023A020, C3025E038, C3023H019, C3025C034, C3024J041, C3025E047, C3025D097, C3022E026, C3024J089, 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Label field

Details supplied by the agency

Lot, code or applicability

Model No. 1110200210; UDI: 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, 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, C3024J039, C3025B080, C3022L055, C3023L009, C3023F017, C3025E018, C3025E097, C3025E043, C3023L013, C3022F009, C3021G001, C3019L006, C3022F017, C3024J002, C3022H017, C3021D019, C3023D017, C3024K112, C3022L052, C3022C004, C3022K024, C3023L045, C3022L058, C3023E032, C3024G003, C3024J083, C3024H018, C3023G033, C3021M014, C3022M013, C3022E022, C3021F004, C3023H023, C3023L020, C3024K026, C3020L004, C3022F002, C3025D079, C3023L023, C3021H013, C3023F029, C3021K005, C3025D032, C3024K115, C3024G027, C3024H017, C3023J032, C3023J038, C3023E033, C3023D005, C3024F010, C3023L018, C3024F009, C3022C010, C3024D024, C3021K001, C3023B036, C3019J014, C3025C027, C3024J006, C3019J008, C3022F016, C3023D055, C3023E031, C3023E039, C3022H012, C3023D042, C3021M015, C3025B117, C3023B012, C3023L028, C3023J040, C3022L019, C3024J009, C3024J010, C3024K055, C3023L039, C3022E027, C3025C023, C3023B043, C3025D034, C3024J087, C3022G018, C3023J012, C3023M027, C3024G007, C3023D046, C3023K028, C3024J052, C3023C005, C3024J037, C3024J093, C3024J079, C3023M023, C3023B019, C3021F014, C3025E009, C3023D019, C3022E015, C3023G032, C3022C023, C3023C014, C3022M011, C3024G009, C3024J076, C3022M003, C3022B013, C3020J007, C3025D044, C3025E008, C3020K010, C3024C015, C3022F007, C3023L022, C3022J026, C3024D029, C3023L016, C3019M004, C3021L004, C3025E067, C3024M062, C3022E023, C3023B039, C3022J001, C3023J033, C3024G019, C3025E092, C3019K010, C3023L024, C3025C030, C3023L046, C3025E016, C3023K029, C3022L053, C3023K045, C3023C007, C3025C021, C3023C004, C3025E020, C3023K023, C3024D005, C3024D001, C3025E057, C3022L037, C3021F007, C3021M012, C3024H038, C3024D004, C3023L042, C3023M019, C3024G025, C3022F008, C3021M013, C3022A037, C3019L003, C3025E090, C3025D088, C3025E012, C3019M005, C3022G017, C3024H026, C3024M056, C3022A008, C3025E010, C3023L015, C3024H036, C3024H035, C3022C012, C3023L038, C3024J080, C3023K025, C3024K118, C3025B007, C3020H005, C3024H039, C3023E034, C3023E028, C3023B001, C3022E032, C3021J020, C3025E042, C3025C032, C3024G023, C3022H026, C3024K028, C3023B037, C3023J009, C3025C025, C3021G021, C3021M003, C3023K038, C3023K033, C3025B035, C3024M061, C3023M026, C3024G013, C3024J092, C3025E096, C3022F019, C3019M003, C3022M015, C3022L013, C3023J016, C3025B077, C3024K019, C3021M008, C3024J082, C3024G021, C3025B029, C3021F002, C3019J015, C3024K024, C3022L050, C3024K053, C3025D033, C3024H019, C3023C015, C3022M012, C3025B114, C3020G004, C3024J051, C3022F003, C3022L017, C3023J010, C3025E040, C3020J009, C3023B038, C3022J032, C3021K019, C3024C014, C3024H025, C3024H022, C3022L004, C3021H015, C3022L011, C3022L034, C3022C024, C3023D020, C3023C022, C3025D062, C3022J022, C3025D092, C3022A004, C3022B010, C3022J003, C3025D041, C3022L054, C3024J007, C3024H069, C3020J003, C3025B110, C3022A010, C3022A005, C3023L021, C3024G006, C3023K032, C3022J031, C3022G013, C3025B116, C3021L033, C3021L032, C3022L021, C3022C006, C3022H023, C3020C008, C3025E068, C3023L006, C3021F006, C3022J023, C3024H032, C3025E005, C3023D054, C3019J016, C3022C027, C3024D003, C3022K025, C3022J007, C3025D093, C3025D078, C3024H042, C3024H078, C3023L040, C3022L008, C3023G012, C3023L077, C3025E098, C3025D026, C3024M054, C3023J008, C3023L031, C3023G017, C3024J048, C3024K049, C3023J003, C3024H012, C3024H013, C3023J030, C3021K018, C3023C021, C3021M006, C3025B004, C3025E015, C3024J077, C3019J009, C3023L032, C3024J008, C3019L005, C3022B008, C3025E055, C3024J074, C3023B013, C3022E021, C3023D004, C3022B014, C3021F005, C3020G005, C3022J034, C3025C033, C3025B030, C3024C011, C3023L025, C3023G018, C3025B075, C3024C016, C3022L051, C3022C005, C3025E053, C3022E025, C3021J019, C3024K048, C3025D090, C3025D064, C3025D091, C3022K021, C3021J031, C3020J010, C3024H062, C3021J002, C3025E007, C3023B020, C3024J040, C3021H012, C3023E030, C3023J031, C3023G011, C3024K031, C3022L032, C3023D009, C3022G016, C3022J004, C3019M010, C3020H004, C3024H023, C3019M002, C3025D031, C3022C026, C3024K017, C3021M020, C3022K017, C3023D013, C3024G015, C3023B021, C3022C025, C3022K022, C3023E025, C3024H073, C3025B112, C3022A001, C3023D057, C3021J021, C3023D047, C3024G020, C3022G019, C3025B006, C3024J085, C3022C008, C3023C019, C3022C003, C3021G004, C3023D003, C3021G003, C3022F004, C3024J053, C3022J013, C3022L045, C3021M009, C3021G005, C3024M057, C3024G012, C3024F028, C3021J004, C3020J015, C3022E018, C3020J011, C3021K022, C3022C007, C3025D077, C3023J015, C3023L017, C3023K039, C3022A006, C3021A006, C3022B009, C3024K018, C3022E031, C3021J005, C3020K008, C3023F018, C3021D001, C3023L075, C3022E033, C3021M002, C3021M001, C3021H014, C3025D087, C3025E070, C3023H018, C3024K052, C3024K032, C3021L002, C3024H076, C3021H016, C3022A029, C3022B007, C3021F015, C3021M017, C3021D020, C3021D023, C3022L029, C3022L030, C3022J005, C3023G015, C3025B008, C3023D010, C3020G006, C3023G027, C3024J005, C3025E058, C3021F003, C3025E059, C3022F018, C3023D051, C3023F026, C3020L007, C3023K040, C3025B032, C3022M002, C3023B024, C3021G002, C3023F023, C3022K018, C3022J006, C3022G010, C3023K037, C3023C003, C3023J035, C3024C020, C3021L003, C3025E061, C3023L074, C3023B003, C3022L015, C3022E019, C3023K021, C3022L002, C3024F029, C3023F027, C3023F028, C3025B005, C3022J021, C3025E024, C3023F024, C3024D022, C3024J004, C3020H001, C3023G030, C3025E037, C3023D052, C3021M021, C3022F013, C3025E031, C3025E022, C3025E026, C3023L008, C3022L020, C3022K011, C3025D104, C3024J001, C3023G028, C3024K029, C3023K026, C3024G011, C3023B022, C3025B010, C3023A025, C3023M025, C3024J050, C3025D038, C3019K001, C3022A030, C3021L006, C3022C028, C3024M063, C3020L005, C3021D015, C3021L029, C3025D089, C3021F009, C3023M022, C3019K007, C3023B011.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Mar 18, 2026
Recall initiation date: Jan 27, 2026
Center classification date: Mar 12, 2026

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

What the record says

Lot and product identifiers

Distribution

Dates in the source

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