| Device |
laryngeal injection set with led light |
| Regulation Description |
Ear, nose, and throat manual surgical instrument. |
| 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 |
| Physical State |
Laryngeal injection set with light guide consists of a light-guided needle used for injection laryngoplasty and a light generator delivers the light energy to the needle tip by generating LED light from an AC-powered light source. The light transmitted from the LED generator is emitted from the tip of fiber optics embedded within the needle tip . Laryngeal injection set with light guide is used for injection laryngoplasty procedures to indicate the injection site with visible light. This system does not contain or deliver drugs. |
| Technical Method |
Laryngeal injection set with light guide consists of a light-guided needle used for injection laryngoplasty and a light generator delivers the light energy to the needle tip by generating LED light from an AC-powered light source. The light transmitted from the LED generator is emitted from the tip of fiber optics embedded within the needle tip . Laryngeal injection set with light guide is used for injection laryngoplasty procedures to indicate the injection site with visible light. This system does not contain or deliver drugs. |
| Target Area |
Laryngeal injection set with light guide is used for injection laryngoplasty to address glottic incompetence to indicate the injection site with visible light |
| Regulation Medical Specialty |
Ear Nose & Throat |
| Review Panel |
Ear Nose & Throat |
|---|
| Product Code | SBS |
|---|
| Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
| Submission Type |
510(K) Exempt
|
|---|
| Regulation Number |
874.4420
|
|---|
| Device Class |
1
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Note: FDA has exempted almost all class I devices (with the exception of reserved devices) from the premarket notification requirement, including those devices that were exempted by final regulation published in the Federal Registers of December 7, 1994, and January 16, 1996. It is important to confirm the exempt status and any limitations that apply with 21 CFR Parts 862-892. Limitations of device exemptions are covered under 21 CFR XXX.9, where XXX refers to Parts 862-892. |
| If a manufacturer's device falls into a generic category of exempted class I devices as defined in 21 CFR Parts 862-892, a premarket notification application and fda clearance is not required before marketing the device in the U.S. however, these manufacturers are required to register their establishment. Please see the Device Registration and Listing website for additional information. |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
