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- MiscellaneousMiscellaneous
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- LOGCatheter, Balloon For Retinal Reattachment3Product Code
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- LZRUltrasound, Cyclodestructive3Product Code
- LZSExcimer Laser System3Product Code
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- P970056BAUSCH & LOMB KERACOR 116 EXCIMER LASER SYSTEMAPWDPMA Approval
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- P970005KREMER LASER SYSTEMAPPRPMA Approval
Show All 15 Submissions
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- MSISolution, Cleaning / Lubricating, Artificial Eye3Product Code
- MTALens, Intraocular, Phakic3Product Code
- MURGraft, Sclera, Reinforcement3Product Code
- MWDElectrosurgical, Radio Frequency, Refractive Correction3Product Code
- NBFProsthesis, RetinalFProduct Code
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- ODKRefractive Corneal ImplantFProduct Code
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- 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
- FDA Hosted 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