Product code LXS

Device name: Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
Medical specialty: Ophthalmic
Device class: 2
Regulation number: 886.4392
Review panel: OP
Implant: N
Life sustaining/supporting: N
GMP exempt: N
Third party review: Y
Summary malfunction reporting: Eligible
Source: FDA openFDA device classification dataset

PMA, Device, Applicant table
PMA	Device	Applicant	Decision date
P830064S003	NEODYMIUM-YAG OP LASER OPL-3	Coburn Optical Ind., Inc.	1986-05-28
P840047	CILCO ND:YAG LASER	Coopervision-Cilco	1985-08-02
P830064S001	NEODYMIUM-YAG OP LASER OPL-3	Coburn Optical Ind., Inc.	1985-02-06
P830064S002	NEODYMIUM-YAG OP LASER OPL-3	Coburn Optical Ind., Inc.	1984-12-13

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K023045	MICRORUPTER V	Meridian AG	2002-09-26
K901605	PHOENIX LASER SYSTEMS OPHTHALMIC SURGICAL WORKSTA.	Phoenix Laser Systems, Inc.	1990-12-13
K895864	MICRORUPTOR III SYST, Q-SWITCHED ND:YAG LASER COMP	Lasag AG	1989-12-29
K893987	NIDEK MODEL YC-1200	Nidek, Inc.	1989-08-18
K892204	NIDEK INC. MODELS YC-2000 & 3000 OPHTHALMIC LASERS	Nidek, Inc.	1989-06-22
K892058	ISL QC 2000	Intelligent Surgical Lasers, Inc.	1989-06-15

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