K232177
- 510(k) number
- K232177
- Device name
- Lightin System, Lightin, Lightin Generator
- Applicant
- Solmedix Co., Ltd. KR
- Product code
- SBS — Laryngeal Injection Set With Led Light
- Decision date
- 2024-07-10
- Date received
- 2023-07-24
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Ear, Nose, Throat
510(k) Summary (official FDA PDF): K232177.pdf
Official FDA record: K232177
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.