CLARITY II Laser System; Model No. 1110200210.
FDA device recall Z-1558-2026 · posted 2026-03-12 · Open, Classified
Recall details
- Recalling firm
- Lutronic Corporation
- Reason for recall
- Reports of devices sparking/popping and potentially burning patients.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- GEX
- Quantity affected
- 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.
- Date initiated
- 2026-01-27
- Date posted
- 2026-03-12
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CLARITY II Laser System (K183566) | Lutronic Corporation | 2019-06-14 |