Product code LLO— Ear, Nose, Throat

FDA has cleared 19 devices under product code LLO between 1985 and 1988, filed by 15 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 19887 clearances
• 19873 clearances
• 19865 clearances
• 19854 clearances

• Cooper Lasersonics, Inc.3 clearances
• Surgical Laser Technologies, Inc.2 clearances
• Laser Media2 clearances
• Trimedyne, Inc.1 clearance
• Surgilase, Inc.1 clearance
• Sharplan Industries, Inc.1 clearance
• Richard Wolf Medical Instruments Corp.1 clearance
• Pilling Co.1 clearance
• Minnesota Laser Corp.1 clearance
• Medical Energy, Inc.1 clearance

• K884815 — SLT CLMD CONTACT LASERSurgical Laser Technologies, Inc.·1988-12-22
• K881499 — SURGILASE YAG 100 FOR GYNECOLOGY USESurgilase, Inc.·1988-04-29
• K880592 — LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USELaser Peripherals, LLC·1988-04-25
• K880170 — MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONSCooper Lasersonics, Inc.·1988-03-24
• K874254 — ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONSMinnesota Laser Corp.·1988-03-04
• K875104 — SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USELaserguide·1988-02-02
• K871876 — MODEL 5050 SURGILASER FOR PULMONARY USELasermatic, Inc.·1988-01-22
• K872351 — FIBERLASE II ND:YAG LASER FOR PULMONARY USELaser Media·1987-12-11
• K870505 — OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPLTrimedyne, Inc.·1987-08-07
• K871511 — SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONSMedical Energy, Inc.·1987-07-21
• K862698 — 6000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTIONCooper Lasersonics, Inc.·1986-08-05
• K861921 — LASER BRONCHOSCOPE SYSTEMPilling Co.·1986-06-02
• K861583 — CO2 LASER BRONCHOSCOPE SYSTEMRichard Wolf Medical Instruments Corp.·1986-05-21
• K861045 — MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICATSharplan Industries, Inc.·1986-04-23
• K855095 — S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWASurgical Laser Technologies, Inc.·1986-02-18
• K852761 — CILAS MODEL YM101Inframed, Inc.·1985-11-14
• K852507 — ND: YAGLASER FOR PALLIATIVE TREAT OF OBSTRUCTIONEndo Lase, Inc.·1985-07-05
• K850432 — LASER BENIGN & MALIGNANT PULMONARY OBSTRUCTIONS-Cooper Lasersonics, Inc.·1985-02-15
• K844869 — FIBERLASE 100 MEDICAL LASER SYSTEMLaser Media·1985-01-14