Laser, Neodymium:yag, Pulmonary Surgery

Product Code: LLO

Ear Nose & Throat Medical Laser Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 874.4500


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as LLO

216Laser, Neodymium:yag, Pulmonary SurgeryEar, Nose, And Throat Microsurgical Carbon Dioxide Laser.

Total Product Life Cycle (TPLC) Devices

216Laser, Neodymium:yag, Pulmonary SurgeryEar, Nose, And Throat Microsurgical Carbon Dioxide Laser.

FDA Consensus Standards

Laser, Neodymium:Yag, Pulmonary Surgery [32410]21 CFR §874.4500 🔎

Pre-market Notifications for LLO

K884815SLT CLMD CONTACT LASERSURGICAL LASER TECHNOLOGIES, INC.
K881499SURGILASE YAG 100 FOR GYNECOLOGY USESURGILASE, INC.
K880592LASEGUIDE 600A, 600B, 400A, 400B FOR PULMONARY USELASER PERIPHERALS LLC.
K880170MODEL 4900 ND:YAG LASER FOR PULMONARY OBSTRUCTIONSCOOPER LASERSONICS, INC.
K875104SURGI-LIGHT DISPOSABLE SYSTEM FOR PULMONOLOGY USELASERGUIDE
K874254ND:YAG SURGICAL LASER FOR PULMONARY APPLICATIONSMINNESOTA LASER CORP.
K872351FIBERLASE II ND:YAG LASER FOR PULMONARY USELASER MEDIA
K871876MODEL 5050 SURGILASER FOR PULMONARY USELASERMATIC, INC.
K871511SL-100 ND:YAG LASER FOR PULMONARY OBSTRUCTIONSMEDICAL ENERGY, INC.
K870505OPTILASE YAG MODEL 1000 SURG LASER SYS/PULMON APPLTRIMEDYNE, INC.
K8626986000 ND:YAG LASER FOR BENIGN/MALIGNANT OBSTRUCTIONCOOPER LASERSONICS, INC.
K861921LASER BRONCHOSCOPE SYSTEMPILLING CO.
K861045MODEL 2100 ND:YAG SURGICAL LASER PULMONARY INDICATSHARPLAN INDUSTRIES, INC.
K855095S.L.T. CONTACT LASER ND:YAG USE IN PULMONARY AIRWASURGICAL LASER TECHNOLOGIES, INC.
K852761CILAS MODEL YM101INFRAMED, INC.

Global Unique Device Identification Database

04055207022658LASER, NEODYMIUM:YAG, PULMONARY SURGERY
04055207022641LASER, NEODYMIUM:YAG, PULMONARY SURGERY
04055207022481LASER, NEODYMIUM:YAG, PULMONARY SURGERY
04055207022474LASER, NEODYMIUM:YAG, PULMONARY SURGERY
24026704715552LASER, NEODYMIUM:YAG, PULMONARY SURGERY
24026704715545LASER, NEODYMIUM:YAG, PULMONARY SURGERY
24026704715538LASER, NEODYMIUM:YAG, PULMONARY SURGERY
24026704715521LASER, NEODYMIUM:YAG, PULMONARY SURGERY
14026704715517LASER, NEODYMIUM:YAG, PULMONARY SURGERY
24026704715507LASER, NEODYMIUM:YAG, PULMONARY SURGERY
24026704715491LASER, NEODYMIUM:YAG, PULMONARY SURGERY
24026704715484LASER, NEODYMIUM:YAG, PULMONARY SURGERY
24026704715477LASER, NEODYMIUM:YAG, PULMONARY SURGERY
24026704715460LASER, NEODYMIUM:YAG, PULMONARY SURGERY
24026704715453LASER, NEODYMIUM:YAG, PULMONARY SURGERY

Maude Adverse Events

SLT CLMD-30 30 WATT ND: YAG LASERUHS2015-09-15
VAPORMAX - HO:YAG SIDE FIRING HANDPIECETRIMEDYNE, INC.2006-05-12
*SLT YAG LASEREXCIM2004-09-21
SHARPLANESC SHARPLAN2004-09-21
SHARPLANESC SHARPLAN LASER2000-07-10
ENDOSTATLASERSCOPE SURGICAL SYSTEMS1998-06-29
SLT-SURGICAL LASER TECHNOLOGIESSURGICAL LASER TECHNOLOGIES, INC.1997-12-22
COHERENT SLIMLINE 550/SNCOHERENT1997-06-09
ARTHROSCOPESTRYKER ENDOSCOPY DIV. STRYKER CORP.1996-02-14
LASERSCOPE LASERLASERSCOPE1996-01-31
DUAL EFFECT BARE LASER FIBERLASER INDUSTRIES, LTD.1995-09-22
DUAL EFFECT BARE LASER FIBERLASER INDUSTRIES, LTD.1995-09-22
SHARPLANSHARPLAN LASER INC.1994-07-29
YAG LASERHERAEUS LASERSONICS1992-08-12
LASERSONICSHERAEUS LASER SONICS1992-07-27
ND:YAGSURGICAL LASER TECHNOLOGY1992-07-10
LASERHERAEUS LASERSONICS1992-03-02
KTP LASERLASERSCOPE1992-01-17
KTP/ND YAG LASER - ENDOSCOPIC LASER FIBERLASERSCOPE1991-12-31

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