Laser For Gastro-urology Use

Product Code: LNK

General & Plastic Surgery 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: 878.4810


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as LNK

2171Laser For Gastro-urology UseLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

Total Product Life Cycle (TPLC) Devices

2171Laser For Gastro-urology UseLaser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology.

FDA Consensus Standards

Laser For Gastro-Urology Use [32410]21 CFR §878.4810 🔎
Laser For Gastro-Urology Use [32150]21 CFR §878.4810 🔎

Pre-market Notifications for LNK

K901723MDL-2000 LASERTRIPTERCANDELA LASER CORP.
K880256MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USESHARPLAN LASERS, INC.
K880193MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USESHARPLAN LASERS, INC.
K880171MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPLCOOPER LASERSONICS, INC.
K875039ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGYSURGILASE, INC.
K874255ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.MINNESOTA LASER CORP.
K874253ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.MINNESOTA LASER CORP.
K873892SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USELASERGUIDE
K873330KTP/532 LASERLASERSCOPE
K872870LASER OPTICAL FIBERS - DISPOSABLEOPTIMED THERAPEUTICS
K872630ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.HGM, INC.
K872350FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USELASER MEDIA
K872031UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEMLASER MEDIA
K871934MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USELASERMATIC, INC.
K871932MODEL 5050 SURGILASER FOR UROLOGY USELASERMATIC, INC.

Maude Adverse Events

LASER PERIPHERALLASER PERIPHERALS2013-05-23
BOSTON SCIENTIFIC DUOTOME SIDELITE 550LUMENIS2011-12-14
DUOTOME SIDELITE 550 FIBER DELIVERY DEVICELUMENIS2010-06-29
AMSGREENLIGHT LASER PROBEAMERICAN MEDICAL SYSTEMS (AMS)2010-06-24
BOSTON SCIENTIFIC SIDELITE 550 LASER FIBERBOSTON SCIENTIFIC2010-06-14
BOSTON SCIENTIFICBOSTON SCIENTIFIC2010-06-10
HOLMIUM LASER FIBER2009-12-29
SLIMLINE EZLUMENIS, INC.2009-09-24
DORNIER MEDLITE 20WATTDORNIER MED TECH AMERICA2009-07-27
MICRONMICRON2009-07-16
*LASER FIBER, 1000 MICRONGYRUS MEDICAL, INC.2009-06-18
*LASER FIBER, 600 MICRONGYRUS MEDICAL, INC.2009-06-18
*LASER FIBER, 1000 MICRONGYRUS MEDICAL, INC.2009-06-18
*LASER FIBERTRIMEDYNE, INC.2009-04-23
BOSTON SCIENTIFIC CORP.2009-04-14
BOSTON SICENTIFICBOSTON SCIENTIFIC2009-01-08
DUO TOME SLIDELITE FIBER DELIVERY DEVICEBOSTON SCIENTIFIC CORPORATION2008-12-16
HOLMIUM LASERTRIMEDYNE, INC.2008-11-21
WAVEFORM2008-11-14
BOSTON SCIENTIFICBOSTON SCIENTIFIC CORPORATION2008-11-11
BOSTON SCIENTIFIC CORPORATIONBOSTON SCIENTIFIC CORPORATION2008-11-11
AMSGREENLIGHT HPS BPH FIBER OPTIC (LASER)AMERICAN MEDICAL SYSTEMS2008-11-04
SLIMLINE EZSLIMLINE EZ2008-10-23
ACCUFLEXBOSTON SCIENTIFIC CORP. (UROLOGY)2008-09-15
SIDEFIBERBIOLITEC, INC2008-09-12
BIOLITIC SIDEFIBER ASSEMBLY, 980NM DIODEBILITEC2008-07-23
HOLMIUM LASER FIBERBOSTON SCIENTIFIC2008-04-07
MINVASIVE LASER FIBER2008-04-03
LASERSCOPE GREENLIGHT HPS BPH FIBERLASERSCOPE2008-01-30
LASERSCOPE GREENLIGHT HPS BPH FIBEROPTICLASERSCOPE2008-01-29
DUO TOME SIDELITE 550LUMENIS2008-01-10
DORNIER HOLMIUM LASER FIBERDORNIER MEDTECH AMERICA, INC.2007-12-20
*FIBER, LASERLASERSCOPE2007-12-06
LUMENIS DUOTOME SIDELITE 550LUMENIS, INC.2007-11-02
GREENLIGHT ADDSTATAMERICAN MEDICAL SYSTEMS/INNOVATION CENTER - SILICON VALLEY2007-10-31
DORNIER HOLMIUM LASER FIBERDORNIER MEDTECH AMERICA, INC.2007-09-20
ACCUFLEXBOSTON SCIENTIFIC CORP.2007-09-20
LUMENIS HOLMIUM 100W LITHOTRAYPSYBOSTON SCIENTIFIC2007-09-13
GREENLIGHT PV FIBER OPTICLASERSCOPE2007-09-13
UNKUNKUNK2007-09-10
LASERSCOPELASERSCOPE2007-08-21
DORNIER HOLMIUM LASER FIBERDORNIER MEDTECH AMERICA, INC.2007-07-13
BUGBEEGREENWALD SURGICAL CO.2007-06-26
QUANTA BAREFIBERFIBERTECH USA, INC.2007-06-14
HOLMIUM BARE SINGLE-USE LASER ACCESORYLASER PERIPHERALS2007-05-04
*LASER LITHOTRIPSERAPPLIED MEDICAL2007-04-20
HOLMIUMBOSTON SCIENTIFIC CORP.2007-04-19
DUOTOME SIDE LITE 550BOSTON SCIENTIFIC2007-04-02
SURGICAL LASERLASERSCOPE2007-03-21
GREENLIGHT PVPLASERSCOPE2007-02-28
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