FDA DevicesClass II
CLARITY II Laser System; Model No. 1110200210.
Published: March 18, 2026Recall ID: Z-1558-2026Category: devicesCountry: US
Reason for Recall / Hazard
Reports of devices sparking/popping and potentially burning patients.
Product Description & Identification
CLARITY II Laser System; Model No. 1110200210.
Additional Source Details
| Field | Value |
|---|---|
| City | Goyang |
| State | N/A |
| Event id | 98372 |
| Address 1 | 219 Sowon-Ro; Deogyang |
| Address 2 | N/A |
| Code info | 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, ... [TRUNCATED] |
| Postal code | N/A |
| Report date | 20260318 |
| Product type | Devices |
| Product quantity | 1,525 units |
| Reason for recall | Reports of devices sparking/popping and potentially burning patients. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260127 |
| Initial firm notification | |
| Center classification date | 20260312 |
Overview
- Recalling FirmLutronic Corporation
- StatusOngoing
- Risk LevelClass II
- DistributionWorldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.