Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

Product Code: LXS

Ophthalmic 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: 886.4392


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as LXS

4339Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting PupillaNd:YAG Laser For Posterior Capsulotomy And Peripheral Iridotomy.

Total Product Life Cycle (TPLC) Devices

4339Laser, Neodymium:yag, Ophthalmic For Posterior Capsulotomy And Cutting PupillaNd:YAG Laser For Posterior Capsulotomy And Peripheral Iridotomy.

FDA Consensus Standards

Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla [32410]21 CFR §886.4392 🔎
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla [29877]21 CFR §886.4392 🔎
Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla [29297]21 CFR §886.4392 🔎

Pre-market Notifications for LXS

K023045MICRORUPTER VMERIDIAN AG
K901605PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.PHOENIX LASER SYSTEMS, INC.
K895864MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMPLASAG AG
K893987NIDEK MODEL YC-1200NIDEK, INC.
K892204NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERSNIDEK, INC.
K892058ISL QC 2000INTELLIGENT SURGICAL LASERS, INC.

Global Unique Device Identification Database

04987669100073Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla

Maude Adverse Events

YC-1800NIDEK CO. LTD.2019-11-20
YC-1800NIDEK CO. LTD.2019-05-16
YC-1800NIDEK CO. LTD.2019-05-16
YC-1800NIDEK CO., LTD2019-01-30
YC-1800NIDEK CO. LTD.2018-06-15
YC-1800NIDEK CO., LTD2018-05-02
YC-1800NIDEK CO., LTD2018-04-27
YC-1800NIDEK CO., LTD2018-04-10
YC-1800NIDEK CO., LTD2018-04-10
YC-1800NIDEK CO. LTD2018-04-10
YC-1800NIDEK CO., LTD2017-11-21
YC-1800NIDEK CO.,LTD2017-10-05
YC-1800NIDEK CO.,LTD2017-08-31
YC-1800NIDEK CO., LTD.2015-09-30
YC-1800NIDEK CO., LTD.2015-09-10
YC-1800NIDEK CO., LTD.2015-07-15
YC-1800NIDEK CO., LTD.2015-07-15
YC-1800NIDEK CO., LTD.2015-07-07
YC-1800NIDEK CO., LTD.2015-07-07
YC-1800NIDEK CO., LTD.2015-07-07
YC-1800NIDEK CO., LTD.2015-07-07
YC-1800NIDEK CO., LTD.2015-07-07
YC-1800NIDEK CO., LTD. HAMACHO PLANT2015-06-29
YC-1800NIDEK CO., LTD. HAMACHO PLANT2015-06-29
YC-1800NIDEK CO., LTD2015-06-26
YC-1800NIDEK CO., LTD.2015-06-11
YC-1800NIDEK CO., LTD.2015-06-11
YC-1800NIDEK CO., LTD.2015-05-28
YC-1800NIDEK CO., LTD.2015-05-28
YC-1800NIDEK CO., LTD2015-05-22
YC-1800NIDEK CO., LTD.2015-05-05
YC-1800NIDEK CO., LTD. HAMACHO PLANT2014-12-23
YC-1800NIDEK CO. LTD.2014-12-16
YC-1800NIDEK CO., LTD.2014-12-10
REVLITEHOYA CONBIO2009-03-02
REVLITEHOYA CONBIO2007-07-10
MEDLITE C6HOYA CONBIO2007-02-07
3000 LE ND: YAG LASERELLEX/ALCON-IRVINE TECHNOLOGY CENTER2007-01-04
MEDLITE C6HOYA CONBIO2006-12-26
2300 ND: YAG LASERALCON-IRVINE TECHNOLOGY CENTER2006-11-22
3000 LE ND: YAG LASERALCON-IRVINE TECHNOLOGY CENTER2006-11-22
MEDLITE C6HOYA CONBIO2006-08-14
MEDLITE C6HOYA CONBIO2005-02-18
3000 LE ND: YAG LASERELLEX, ALCON-IRVINE TECHNOLOGY CTR2004-12-24
3000 LE ND: YAG LASERALCON - IRVINE TECHNOLOGY CENTER2002-06-22
DORNIER MEDILAS EDORNIER MEDTECH SYSTEMS GMBH2002-04-25
OPHTHALAS 532 LASERALCON - IRVINE TECHNOLOGY CENTER2001-03-29
UNKYAG LASER MACHINE*2001-01-31
2500 LE ND: YAG LASERALCON - IRVINE TECHNOLOGY CENTER2001-01-05
2500 LE ND: YAG LASERALCON - IRVINE TECHNOLOGY CENTER2001-01-05
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