Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- 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)
- K090938FLOW CONTROLLERUCleared 510(K)
- K061398SNUG PLUG PUNCTUM PLUGUCleared 510(K)
- K053333EAGLEVISION GELLANSERTS, MODEL REF 0040UCleared 510(K)
- K050851DELTA PUNCTUM PLUGUCleared 510(K)
- K040912HYDROGEL CANALICULAR PLUGUCleared 510(K)
- K040231INTELIPORT OCCLUDING DEVICEUCleared 510(K)
- K030300OPAQUE HERRICK LACRIMAL PLUGUCleared 510(K)
- K022043SMART PLUG, MODEL 500; SMARTPLUG FORCEPS, MODEL 502; PUSH ROD, MODEL 503UCleared 510(K)
- K021936MOIST PUNCTAL PLUG SYSTEMUCleared 510(K)
- K020882SHARPOINT ULTRAPLUG EXTENDED WEAR PLUGUCleared 510(K)
- K021831OPAQUE HERRICK LACRIMAL PLUG, 0.3MM,0.5MM,0.7MM, MODELS HLP3-OPB,HLP50OPB,HLP7-OPBUCleared 510(K)
- K013613SOFT PLUG ABSORBABLE PLUG-SAUCleared 510(K)
- K001768OCCU-FLO PUNCTUM PLUGSUCleared 510(K)
- K001234BIOINSULATED SILICONE PUNCTUM PLUGUCleared 510(K)
- K001737OPAQUE HERRICK PLUG, 0.3MM; 0.5MM; O.7MMUCleared 510(K)
- K991130FLEXPLUGUCleared 510(K)
- K980844SURGIDEV SILICONE PUNCTUM PLUGUCleared 510(K)
- K980437SILICONE PUNCTAL PLUGUCleared 510(K)
- K972523PUNCTUAL OCCLUDERUCleared 510(K)
- K970631PUNCTUAL OCCLUDERUCleared 510(K)
- K963708HERRICK ULTIMATE PUNCTUM PLUGUCleared 510(K)
- K963501HERRICK ULTIMATE PUNCTUM PLUGUCleared 510(K)
- K964774PUNCTUM PLUGS & READY-SET PUNCTAL PLUGSUCleared 510(K)
- K961909READY-SET PUNCTAL PLUGSUCleared 510(K)
- K953394VISITEC COLLAR BUTTON CATHETER {GRIFFITHS}UCleared 510(K)
- K954094OPHTA SIL- PUNCTAL PLUGS (MODIFICATION)UCleared 510(K)
- K950569OPHTA SIL {SELF-THREADING MONOKA (RITLENG TYPE)}UCleared 510(K)
- K946357COLLAGEN INTRACANALICULAR PLUGUCleared 510(K)
- K945906SILICONE PUNCTAL PLUGUCleared 510(K)
- K915809VISITEC CANALICULAR STENTUCleared 510(K)
- K905427EAGLE VISION FREEMAN RADIOPAGUE PUNCTUM PLUGUCleared 510(K)
- K911108OPHTA SIL (R), PUNCTAL PLUGS AND INSERTERSUCleared 510(K)
- K905750LACRIMAL PLUGUCleared 510(K)
- K897190LOOK TEMPORARY INTRACANALICULAR COLLAGEN IMPLANTUCleared 510(K)
- K896175HERRICK LACRIMAL PLUG TM.UCleared 510(K)
- K895342COLLAGEN IMPLANTS FOR THE LACRIMAL EFFICIENCY TESTUCleared 510(K)
- K890714LACRIMAL EFFICIENCY TEST (TM)UCleared 510(K)
- K890919TEMPORARY INTRACANALICULAR COLLAGEN IMPLANTUCleared 510(K)
- K890920EAGLE VISION-FREEMAN(TM) PUNCTAL VALVEUCleared 510(K)
- 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
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
READY-SET PUNCTAL PLUGS
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K961909
- 510(k) Type
- Traditional
- Applicant
- FCI OPHTHALMICS, INC.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 7/25/1996
- Days to Decision
- 70 days
- Submission Type
- Statement