Class 2 Device Recall CLARITY II

• Date Initiated by Firm: January 27, 2026
• Date Posted: March 12, 2026
• Recall Status: Open, Classified
• Recall Number: Z-1558-2026
• Recall Event ID: 98372
• 510(K)Number: K183566
• Product Classification: Powered laser surgical instrument - Product Code GEX
• Product: CLARITY II Laser System; Model No. 1110200210.
• Code Information: 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.
• FEI Number: 3004483538
• Recalling Firm/ Manufacturer: Lutronic Corporation; 219 Sowon-Ro; Deogyang; Goyang Korea (the Republic of)
• For Additional Information Contact: Cynosure Lutronic Clinical Support; 844-3655060
• Manufacturer Reason for Recall: Reports of devices sparking/popping and potentially burning patients.
• FDA Determined Cause: Device Design
• Quantity in Commerce: 1,525 units
• Distribution: Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = GEX