# K232177: Lightin System, Lightin, Lightin Generator

- Pathway: 510(k) (Traditional)
- Applicant: Solmedix Co., Ltd.
- Decided: Jul 10, 2024 after 352 days
- Product code: SBS (Laryngeal Injection Set With Led Light)
- Device class: 1
- Regulation: 21 CFR 874.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Symmetry Surgical: named in the summary without a submission number
- (no number) Aesculap® Led Light Source: named in the summary without a submission number

## Indications for use
Lightin is a needle for injection laryngoplasty with an optical fiber. Lightin Generator is an AC-powered light source including Light Guide which is fiber optic cable that transmits light at the tip of fiber optics embedded within Lightin. Lightin System is used for injection laryngoplasty to address glottic incompetence to indicate the injection site with visible light.

Source page: https://510kreport.com/device/K232177
Methodology: https://510kreport.com/methodology