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- MiscellaneousMiscellaneous
- OGOIntraocular Pressure Lowering Implant3Product Code
- QQUDigital Therapy Device For Amblyopia2Product Code
- HPXLens, Contact (Polymethylmethacrylate)UProduct Code
- LOGCatheter, Balloon For Retinal Reattachment3Product Code
- LOHSystem, Identification, Contact Lens3Product Code
- LOILaser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary3Product Code
- LQBMedical Computers And Software For Ophthalmic Use3Product Code
- LQEImplant, Corneal, Refractive3Product Code
- LXQCup, EyeUProduct Code
- LYXMedia, Corneal StorageUProduct Code
- LZQTissue Adhesive For Ophthalmic Use3Product Code
- LZRUltrasound, Cyclodestructive3Product Code
- LZSExcimer Laser System3Product Code
- P060004MEL 80 EXCIMER LASER SYSTEMAPPRPMA Approval
- P030008WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEMAPPRPMA Approval
- P020050WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEMAPPRPMA Approval
- P990027TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z)APPRPMA Approval
- P990010VISX EXCIMER LASER SYSTEM MODEL C STARAPPRPMA Approval
- P980008LASERSCAN LSX EXCIMER LASER SYSTEMAPPRPMA Approval
- P970056BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEMAPWDPMA Approval
- P970053EC-5000 EXCIMER LASER SYSTEMAPPRPMA Approval
- P970043LADARVISION EXCIMER LASER SYSTEMAPWDPMA Approval
- P970005KREMER LASER SYSTEMAPPRPMA Approval
Show All 15 Submissions
- LZUPlug, PunctumUProduct Code
- MRJRing, Endocapsular3Product Code
- MSISolution, Cleaning / Lubricating, Artificial Eye3Product Code
- MTALens, Intraocular, Phakic3Product Code
- MURGraft, Sclera, Reinforcement3Product Code
- MWDElectrosurgical, Radio Frequency, Refractive Correction3Product Code
- NBFProsthesis, RetinalFProduct Code
- NCJTelescope, Implantable, Miniature3Product Code
- ODKRefractive Corneal ImplantFProduct Code
- OKSLacrimal Stents And Intubation SetsUProduct Code
- OTLFemtosecond Laser System For Refractive Correction3Product Code
- OXWStimulator, Electrical, Transcutaneous, For Diabetic RetinopathyNProduct Code
- PFZOphthalmic Sealant3Product Code
- QBTArtificial Iris3Product Code
- QITDaily Wear Soft Contact Lens To Reduce The Progression Of Myopia3Product Code
- QCWCorneal Storage Media With Preservatives Including Anti-Fungal2Product Code
- SAXHome Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device2Product Code
- QQJApplicator, Negative Pressure, External, Ocular2Product Code
- SDELight Based Device For Dry Age-Related Macular Degeneration2Product Code
- QURPrescription Spectacle Lenses To Reduce The Progression Of Myopia2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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EC-5000 EXCIMER LASER SYSTEM
- Page Type
- PMA Approval
- PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- NIDEK CO., LTD.
- Trade Name
- EC-5000 EXCIMER LASER SYSTEM
- Generic Name
- Excimer laser system
- Decision Date
- 12/17/1998
- Days to Decision
- 406 days
- Decision Code
- APPR
- FDA Decision
- Approval