Lutronic Corporation 219 Sowon-ro; Deogyang Goyang Korea (the Republic Of): Powered Laser Surgical Instrument
- Recalling firm
- Lutronic Corporation 219 Sowon-Ro; Deogyang Goyang Korea (the Republic of)
- Product
- CLARITY II Laser System; Model No. 1110200210.
- Reason
- Reports of devices sparking/popping and potentially burning patients.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-27
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, South Korea, Hong Kong, Japan, Singapore, Vietnam, Myanmar, Philippines, Taiwan, and Thailand.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/6b3f1349-dd48-4bcb-a349-c155c7db472d