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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
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- LZQTissue Adhesive For Ophthalmic Use3Product Code
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- MWDElectrosurgical, Radio Frequency, Refractive Correction3Product Code
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- 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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Digital Therapy Device For Amblyopia
- Page Type
- Product Code
- Definition
- A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia.
- Physical State
- Therapeutic algorithms delivered by software. The software needs to work with a visual display, either third-party or integrated hardware. The visual display may be a head-mounted display, tablet, computer screen, etc.
- Technical Method
- The device digitally modifies images or videos such that they are perceived differentially by the amblyopic eye and the fellow eye. The image or video modifications penalize the fellow eye (e.g., by reducing contrast or visibility) and, therefore, encourage the use of the amblyopic eye. The device may apply digital masks on the images or videos for both eyes. The pattern of the mask for one eye is complementary to that for the other eye to encourage binocular fusion.
- Target Area
- Eye
- Regulation Medical Specialty
- Ophthalmic
- Review Panel
- Ophthalmic
- Submission Type
- 510(K)
- Device Classification
- Class 2
- Regulation Number
- 886.5500
- 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 QQU is linked to regulation 21CFR886.5500, which does not seem to exist yet. It may be pending at the moment.