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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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Femtosecond Laser System For Refractive Correction
- Page Type
- Product Code
- Definition
- Ophthalmic femtosecond laser intended to provide refractive vision correction by modification of the shape of the cornea
- Physical State
- The device consists of a laser console, a computer with graphic user interface, a beam delivery system that positions and focuses the laser beam, patient bed, and a patient interface system that flattens the cornea and holds the patient's eye still during the surgical procedure.
- Technical Method
- The laser console generates femtosecond laser pulses. When focused in transparent tissue, these low energy pulses produce photodisruption (a highly localized region of ionized plasma) effects that occur on an extremely short time scale and are confined to the few microns surrounding the focal spot. Patterns of contiguous, focused laser pulses result in the creation of cut surfaces in the cornea that define a disc-shaped tissue (lenticule) in the corneal stroma. The surgeon enters treatment parameters and a corresponding lenticule is created according to a pre-defined algorithm such that its thickness determines the refractive correction and resultant corneal reshaping when extracted.
- Target Area
- Cornea of the eye.
- Review Panel
- Ophthalmic
- Submission Type
- PMA
- Device Classification
- Class 3
- GMP Exempt?
- No
- Summary Malfunction Reporting
- Ineligible
- Implanted Device
- No
- Life-Sustain/Support Device
- No
- Third Party Review
- Not Third Party Eligible
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No Linked CFR Text
The FDA has not linked product code OTL to any particular section of the CFR (Code of Federal Regulations). There are multiple reasons why this might be the case:
- The product code was created for a class III submission that does not follow the normal PMN or PMA path - e.g., for a device that falls under HDE (Humanitarian Device Exemption) or EUA (Emergency Use Authorization).
- The FDA has generated the product code for an existing Class III device, as a result of a PMA supplement that modifies the device in a way that it can't fit under the existing product code originally assigned
- The product code was created for internal use at the FDA, and not for classification or regulatory-related purposes.