K232177 is an FDA 510(k) clearance for the Lightin System, Lightin, Lightin Generator. This device is classified as a Laryngeal Injection Set With Led Light (Class I - General Controls, product code SBS).
Submitted by Solmedix Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on July 10, 2024, 352 days after receiving the submission on July 24, 2023.
This device falls under the Ear, Nose, Throat FDA review panel. Regulated under 21 CFR 874.4420. 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.
| 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 |
| Product Code | SBS - Laryngeal Injection Set With Led Light |
| Device Class | Class I - 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 |