LLO · Laser, Neodymium:Yag, Pulmonary Surgery
Ear, Nose, Throat · 21 CFR 874.4500 · Class 2
Overview
| Product Code | LLO |
|---|---|
| Device Name | Laser, Neodymium:Yag, Pulmonary Surgery |
| Regulation | 21 CFR 874.4500 |
| Device Class | Class 2 |
| Review Panel | Ear, Nose, Throat |
| 3rd-Party Reviewable | Yes |
Identification
An ear, nose, and throat microsurgical carbon dioxide laser is a device intended for the surgical excision of tissue from the ear, nose, and throat area. The device is used, for example, in microsurgical procedures to excise lesions and tumors of the vocal cords and adjacent areas.
Classification Rationale
Class II.
Cleared Devices (19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K884815 | SLT CLMD CONTACT LASER | Surgical Laser Technologies, Inc. | Dec 22, 1988 | SESE |
| K881499 | SURGILASE YAG 100 FOR GYNECOLOGY USE | Surgilase, Inc. | Apr 29, 1988 | SESE |
| K880592 | LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USE | Laser Peripherals, LLC | Apr 25, 1988 | SESE |
| K880170 | MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | Cooper Lasersonics, Inc. | Mar 24, 1988 | SESE |
| K874254 | ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONS | Minnesota Laser Corp. | Mar 4, 1988 | SESE |
| K875104 | SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USE | Laserguide | Feb 2, 1988 | SESE |
| K871876 | MODEL 5050 SURGILASER FOR PULMONARY USE | Lasermatic, Inc. | Jan 22, 1988 | SESE |
| K872351 | FIBERLASE II ND:YAG LASER FOR PULMONARY USE | Laser Media | Dec 11, 1987 | SESE |
| K870505 | OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPL | Trimedyne, Inc. | Aug 7, 1987 | SESE |
| K871511 | SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONS | Medical Energy, Inc. | Jul 21, 1987 | SESE |
| K862698 | 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTION | Cooper Lasersonics, Inc. | Aug 5, 1986 | SESE |
| K861921 | LASER BRONCHOSCOPE SYSTEM | Pilling Co. | Jun 2, 1986 | SESE |
| K861583 | CO2 LASER BRONCHOSCOPE SYSTEM | Richard Wolf Medical Instruments Corp. | May 21, 1986 | SESE |
| K861045 | MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICAT | Sharplan Industries, Inc. | Apr 23, 1986 | SESE |
| K855095 | S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWA | Surgical Laser Technologies, Inc. | Feb 18, 1986 | SESE |
| K852761 | CILAS MODEL YM101 | Inframed, Inc. | Nov 14, 1985 | SESE |
| K852507 | ND: YAGLASER FOR PALLIATIVE TREAT OF OBSTRUCTION | Endo Lase, Inc. | Jul 5, 1985 | SESE |
| K850432 | LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS- | Cooper Lasersonics, Inc. | Feb 15, 1985 | SESE |
| K844869 | FIBERLASE 100 MEDICAL LASER SYSTEM | Laser Media | Jan 14, 1985 | SESE |
Top Applicants
- Cooper Lasersonics, Inc. — 3 clearances
- Surgical Laser Technologies, Inc. — 2 clearances
- Laser Media — 2 clearances
- Trimedyne, Inc. — 1 clearance
- Surgilase, Inc. — 1 clearance
