Lightin System, Lightin, Lightin Generator

K232177510(k) TraditionalCleared Jul 10, 2024352-day reviewClass I21 CFR 874.4420

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Solmedix Co., Ltd. · SBS Laryngeal Injection Set With Led Light

Cleared on Jul 10, 2024 after a 352-day review. The FDA summary names its predicate without a number.

Decided: Jul 10, 2024
Review: 352 days
Class: Class I
Product code: SBS
Recalls: None
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K232177Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in SBS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	Symmetry Surgical Named without a submission number			—
*	—	Aesculap® Led Light Source Named without a submission number			—
†	K151604	23ga Chandelier Illuminator, 25ga Chandelier Illuminator	Peregrine Surgical, Ltd.	2015	—
†	K233037	Sterile Hypodermic Needles for Single Use	Zhejiang Kindly Medical Device Co., Ltd.	2023	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All SBS devices

SBS Laryngeal Injection Set With Led Light: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · SBS

1in 2024

2007high 1 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · SBS

Too few SBS 510(k)s in any year since 2007 to give a median.

Recalls per year · SBS

No recall names SBS since 2007.

Adverse event reports per year · SBS

No MAUDE report names SBS since 2007.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	0	—	0
2011	0	—	0
2012	0	—	0
2013	0	—	0
2014	0	—	0
2015	0	—	0
2016	0	—	0
2017	0	—	0
2018	0	—	0
2019	0	—	0
2020	0	—	0
2021	0	—	0
2022	0	—	0
2023	0	—	0
2024	1	—	0
2025	0	—	0
2026	0	—	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K232177 · printed Nov 6, 2026

Cite this page

510(k) Report. “K232177: Lightin System, Lightin, Lightin Generator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232177

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026