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OGO
Intraocular Pressure Lowering Implant
3
Product Code
QQU
Digital Therapy Device For Amblyopia
2
Product Code
HPX
Lens, Contact (Polymethylmethacrylate)
U
Product Code
LOG
Catheter, Balloon For Retinal Reattachment
3
Product Code
LOH
System, Identification, Contact Lens
3
Product Code
LOI
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
3
Product Code
P
99
0078
HYPERION LTK SYSTEM
APPR
PMA Approval
K
88
1459
NANOLAS ND:YAG OPHTHALMIC LASER
3
Cleared 510(K)
P
85
0091
YAGMASTER ND:YAG OP LASER
APWD
PMA Approval
P
83
0080
PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER
APPR
PMA Approval
P
85
0063
MICRO YAG ND:YAG LASER SYSTEM
APWD
PMA Approval
P
84
0012
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM
APWD
PMA Approval
P
85
0019
PHOTOTOME(TM) SYSTEM 2700
APPR
PMA Approval
P
83
0025
MEDITEC OPL3 ND:YAG LASER
APPR
PMA Approval
P
83
0062
ND:YAG POSTERIOR CAPSULOTOMY MODEL 100
APWD
PMA Approval
P
83
0054
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900
APPR
PMA Approval
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3
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U
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U
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3
Product Code
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3
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3
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3
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N
Product Code
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3
Product Code
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3
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Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
3
Product Code
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2
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Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
2
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2
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Last synced on 16 May 2025 at 11:05 pm
OP
/
OP-misc
/
LOI
/
P840012
View Source
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
MERIDIAN AG
Trade Name
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM
Generic Name
Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
Decision Date
1/31/1986
Days to Decision
683 days
Decision Code
APWD
FDA Decision
Withdrawal after approval
FDA Browser
by
Innolitics
Anesthesiology
Cardiovascular
Chemistry
Dental
Ear, Nose, Throat
Gastroenterology and Urology
General Hospital
Hematology
Immunology
Microbiology
Neurology
Obstetrical and Gynecological
Ophthalmic
Miscellaneous
OGO
Intraocular Pressure Lowering Implant
QQU
Digital Therapy Device For Amblyopia
HPX
Lens, Contact (Polymethylmethacrylate)
LOG
Catheter, Balloon For Retinal Reattachment
LOH
System, Identification, Contact Lens
LOI
Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary
P
99
0078
HYPERION LTK SYSTEM
K
88
1459
NANOLAS ND:YAG OPHTHALMIC LASER
P
85
0091
YAGMASTER ND:YAG OP LASER
P
83
0080
PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEER
P
85
0063
MICRO YAG ND:YAG LASER SYSTEM
P
84
0012
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM
P
85
0019
PHOTOTOME(TM) SYSTEM 2700
P
83
0025
MEDITEC OPL3 ND:YAG LASER
P
83
0062
ND:YAG POSTERIOR CAPSULOTOMY MODEL 100
P
83
0054
NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900
LQB
Medical Computers And Software For Ophthalmic Use
LQE
Implant, Corneal, Refractive
LXQ
Cup, Eye
LYX
Media, Corneal Storage
LZQ
Tissue Adhesive For Ophthalmic Use
LZR
Ultrasound, Cyclodestructive
LZS
Excimer Laser System
LZU
Plug, Punctum
MRJ
Ring, Endocapsular
MSI
Solution, Cleaning / Lubricating, Artificial Eye
MTA
Lens, Intraocular, Phakic
MUR
Graft, Sclera, Reinforcement
MWD
Electrosurgical, Radio Frequency, Refractive Correction
NBF
Prosthesis, Retinal
NCJ
Telescope, Implantable, Miniature
ODK
Refractive Corneal Implant
OKS
Lacrimal Stents And Intubation Sets
OTL
Femtosecond Laser System For Refractive Correction
OXW
Stimulator, Electrical, Transcutaneous, For Diabetic Retinopathy
PFZ
Ophthalmic Sealant
QBT
Artificial Iris
QIT
Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia
QCW
Corneal Storage Media With Preservatives Including Anti-Fungal
SAX
Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
QQJ
Applicator, Negative Pressure, External, Ocular
SDE
Light Based Device For Dry Age-Related Macular Degeneration
Submissions with No Product Code
Subpart B—Diagnostic Devices
Subpart D—Prosthetic Devices
Subpart E—Surgical Devices
Subpart F—General Hospital and Personal Use Therapeutic Devices
Subpart F—Therapeutic Devices
Orthopedic
Pathology
Physical Medicine
Radiology
General and Plastic Surgery
Toxicology
Medical Genetics
Unknown
OP
/
OP-misc
/
LOI
/
P840012
View Source
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM
Page Type
PMA Approval
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
Applicant
MERIDIAN AG
Trade Name
MICRORUPTOR MR-2 ND:YAG LASER SYSTEM
Generic Name
Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
Decision Date
1/31/1986
Days to Decision
683 days
Decision Code
APWD
FDA Decision
Withdrawal after approval