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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
- LZUPlug, PunctumUProduct Code
- K241229Hello,eyes® BIO PlugUCleared 510(K)
- K222164Visant Medical Canalicular PlugUCleared 510(K)
- K213988SOFT PLUG Extended Duration 180 Tapered Canalicular PlugUCleared 510(K)
- K190210Tear Pool Dissolvable Punctum PlugsUCleared 510(K)
- K162361Soft Plug Extended Duration 180 Canalicular PlugUCleared 510(K)
- K161673LacriPro Punctum PlugUCleared 510(K)
- K150288PDO Absorbable Punctum PlugUCleared 510(K)
- K140352VERAPLUGUCleared 510(K)
- K140711COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,UCleared 510(K)
- K140026COLLASYN PLUG FOR THE LACRIMAL EFFICIENCY TESTUCleared 510(K)
Show All 49 Submissions
- 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
- 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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COMFORTEAR LACRISOLVE ABSORBABLE PUNCTUM PLUG, LACRISOLVE ABSORBABLE PUNCTUM PLUG, COMFORTEAR LACRISOLVE PUNCTUM PLUG,
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K140711
- 510(k) Type
- Traditional
- Applicant
- PARAGON BIOTECK, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/20/2014
- Days to Decision
- 91 days
- Submission Type
- Summary