Clearance Summary
Lightin System, Lightin, Lightin Generator received FDA 510(k) clearance under submission number K232177, sponsored by Solmedix Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ear, Nose, Throat review panel. The statutory decision date of record is 2024-07-10.
- Submission: K232177
- Applicant / Sponsor: Solmedix Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Ear, Nose, Throat
- Device class: Class I
- Regulation citation: 21 CFR 874.4420
- Decision date: 2024-07-10
Classification & Regulation
This clearance is catalogued under FDA product code SBS and 21 CFR 874.4420, within the Ear, Nose, Throat review panel as a Class I device.