510(k) K232177
- Device
- Lightin System, Lightin, Lightin Generator
- Applicant
- Solmedix Co., Ltd.
- 510(k) number
- K232177
- Product code
- SBS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-07-10
- Date received
- 2023-07-24
- Regulation
- 874.4420
- Classification name
- Laryngeal Injection Set With Led Light
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Hyeroung Lee
- Address
- #706, 330, Seongarm-Ro, Mapo-Gu Seoul KR 03920 03920
FDA Registration Numbers
- 3040387472