FDA.reportPublic FDA data

510(k) K861583

Device
Co2 Laser Bronchoscope System
Applicant
RICHARD WOLF MEDICAL INSTRUMENTS CORP.
510(k) number
K861583
Product code
LLO
Decision
Substantially Equivalent (SESE)
Decision date
1986-05-21
Date received
1986-04-29
Regulation
874.4500
Classification name
Laser, Neodymium:Yag, Pulmonary Surgery
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
CHARLES P GILL
Address
7046 Lyndon Ave. Rosemont IL US 60018 60018

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LLO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K884815SLT CLMD CONTACT LASERSurgical Laser Technologies, Inc.1988-12-22
K881499SURGILASE YAG 100 FOR GYNECOLOGY USESurgilase, Inc.1988-04-29
K880592LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USELaser Peripherals, LLC1988-04-25
K880170MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONSCooper Lasersonics, Inc.1988-03-24
K874254ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONSMinnesota Laser Corp.1988-03-04
K875104SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USELaserguide1988-02-02
K871876MODEL 5050 SURGILASER FOR PULMONARY USELasermatic, Inc.1988-01-22
K872351FIBERLASE II ND:YAG LASER FOR PULMONARY USELaser Media1987-12-11
K870505OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPLTrimedyne, Inc.1987-08-07
K871511SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONSMedical Energy, Inc.1987-07-21
K8626986000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTIONCooper Lasersonics, Inc.1986-08-05
K861921LASER BRONCHOSCOPE SYSTEMPilling Co.1986-06-02
K861045MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICATSharplan Industries, Inc.1986-04-23
K855095S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWASurgical Laser Technologies, Inc.1986-02-18
K852761CILAS MODEL YM101Inframed, Inc.1985-11-14