[pending] CLARITY II Laser System; Model No. 1110200210.
Pending LLM rewrite. Source: FDA_DEVICE Z-1558-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Reports of devices sparking/popping and potentially burning patients.
The recalled product
- Product
- CLARITY II Laser System; Model No. 1110200210.
- Manufacturer
- Lutronic Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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