510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K232177Substantially Equivalent

Lightin System, Lightin, Lightin Generator

Solmedix Co., Ltd., Seoul, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K232177 is the FDA 510(k) clearance record for Lightin System, Lightin, Lightin Generator, a class I device, cleared for Solmedix Co., Ltd. on under FDA product code SBS (Laryngeal Injection Set With Led Light). FDA's definition for product code SBS reads: "A light guided laryngeal injection set is an ear, nose, and throat manual surgical instrument and is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx...". FDA records list one 510(k) clearance for Solmedix Co., Ltd. As of , FDA records show no recalls naming K232177.

Clearance record

Decision date
Received
(352 days to decision)
Product code
SBS Laryngeal Injection Set With Led Light
Regulation
21 CFR 874.4420
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Solmedix Co., Ltd. #706, 330, Seongarm-Ro, Mapo-Gu, Seoul, KR
510(k) summary
Summary PDF
Third party review
No

Clearances, product code SBS

Trailing 12 months

FDA records hold no clearances under product code SBS in the trailing twelve months.

FDA records show no clearances under product code SBS in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SBS, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260