Lightin System, Lightin, Lightin Generator
FDA 510(k) clearance K232177 · decided 2024-07-10
Clearance details
- K-number
- K232177
- Device name
- Lightin System, Lightin, Lightin Generator
- Applicant
- Solmedix Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-07-24
- Decision date
- 2024-07-10
- Days to decision
- 352 days
- Clearance type
- Traditional
- Product code
- SBS
- Device class
- 1
- Regulation number
- 874.4420
- Medical specialty
- Ear, Nose, Throat
- Advisory committee
- Ear, Nose, Throat
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.