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- MiscellaneousMiscellaneous
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- 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
- P990078HYPERION LTK SYSTEMAPPRPMA Approval
- K881459NANOLAS ND:YAG OPHTHALMIC LASER3Cleared 510(K)
- P850091YAGMASTER ND:YAG OP LASERAPWDPMA Approval
- P830080PICOLAS NEODYMIUN-YAG OPHTHALMIC LASEERAPPRPMA Approval
- P850063MICRO YAG ND:YAG LASER SYSTEMAPWDPMA Approval
- P840012MICRORUPTOR MR-2 ND:YAG LASER SYSTEMAPWDPMA Approval
- P850019PHOTOTOME(TM) SYSTEM 2700APPRPMA Approval
- P830025MEDITEC OPL3 ND:YAG LASERAPPRPMA Approval
- P830062ND:YAG POSTERIOR CAPSULOTOMY MODEL 100APWDPMA Approval
- P830054NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900APPRPMA Approval
- LQBMedical Computers And Software For Ophthalmic Use3Product Code
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- OXWStimulator, Electrical, Transcutaneous, For Diabetic RetinopathyNProduct Code
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- 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
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- SDELight Based Device For Dry Age-Related Macular Degeneration2Product Code
- Submissions with No Product CodeMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
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- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
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ND:YAG POSTERIOR CAPSULOTOMY MODEL 100
- Page Type
- PMA Approval
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- Applicant
- NIDEK, INC.
- Trade Name
- ND:YAG POSTERIOR CAPSULOTOMY MODEL 100
- Generic Name
- Laser, neodymium:Yag, ophthalmic for uses other than posterior capsulotomy & cutting pupillary
- Decision Date
- 9/27/1984
- Days to Decision
- 611 days
- Decision Code
- APWD
- FDA Decision
- Withdrawal after approval