Cleared Traditional

K232177 - Lightin System, Lightin, Lightin Generator (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K232177 · Solmedix Co., Ltd. · Ear, Nose, Throat device
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Optimized for regulatory review, auditing and printing
Jul 2024
Decision
352d
Days
Class 1
Risk

K232177 is an FDA 510(k) clearance for the Lightin System, Lightin, Lightin Generator. Classified as Laryngeal Injection Set With Led Light (product code SBS), Class I - General Controls.

Submitted by Solmedix Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on July 10, 2024 after a review of 352 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.4420 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Solmedix Co., Ltd. devices

Submission Details

510(k) Number K232177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2023
Decision Date July 10, 2024
Days to Decision 352 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
263d slower than avg
Panel avg: 89d · This submission: 352d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code SBS Laryngeal Injection Set With Led Light
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.4420
Definition 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, Nasal And Paranasal Sinus, Or Ear. This Generic Type Of Device Includes The Esophageal Dilator; Tracheal Bistour (a Long, Narrow Surgical Knife); Tracheal Dilator; Tracheal Hook; Laryngeal Injection Set; Laryngeal Knife; Laryngeal Saw; Laryngeal Trocar; Laryngectomy Tube; Adenoid Curette; Adenotome; Metal Tongue Depressor; Mouth Gag; Oral Screw; Salpingeal Curette; Tonsillectome; Tonsil Guillotine; Tonsil Screw; Tonsil Snare; Tonsil Suction Tube; Tonsil Suturing Hook; Antom Reforator; Ethmoid Curette; Frontal Sinus-rasp; Nasal Curette; Nasal Rasp; Nasal Rongeur; Nasal Saw; Nasal Scissors; Nasal Snare; Sinus Irrigator; Sinus Trephine; Ear Curette; Ear Excavator; Ear Rasp; Ear Scissor, Ear Snare; Ear Spoon; Ear Suction Tube; Malleous Ripper; Mastoid Gauge; Microsurgical Ear Chisel; Myringotomy Tube Inserter; Ossici Holding Clamp; Sacculotomy Tack Inserter; Vein Press; Wire Ear Loop; Microrule; Mirror; Mobilizer; Ear, Nose, And Throat Punch; Ear, Nose And Throat Knife; And Ear, Nose, And Throat Trocar
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.