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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
- 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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Applicator, Negative Pressure, External, Ocular
- Page Type
- Product Code
- Definition
- External ocular negative pressure system. An external ocular negative pressure system uses hardware and software to create negative pressure in front of the eye to temporarily lower intraocular pressure in glaucoma patients.
- Physical State
- Goggles and pump unit
- Technical Method
- Creation of vacuum with pump
- Target Area
- Ocular
- Regulation Medical Specialty
- Ophthalmic
- Review Panel
- Ophthalmic
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 886.5000
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
- MAUDE Alerts
- View and Sign Up For MAUDE Alerts
No Linked CFR Text
Product code QQJ is linked to regulation 21CFR886.5000, which does not seem to exist yet. It may be pending at the moment.