United StatesThe CLARITY II Laser System (Model No. 1110200210; UDI 08809447653723), distributed worldwide including the United States, Canada and several Asian countries, is being recalled — affected units are identified by that model number and UDI. The recall was issued after reports of devices sparking or popping and potentially burning patients.
What's being recalled
CLARITY II Laser System; Model No. 1110200210.
Recalling firm: Lutronic Corporation, Goyang, N/A, Korea (the Republic of).
How to identify it
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…
The hazard
Reports of devices sparking/popping and potentially burning patients.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was sold
Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)