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U.S. Department of Health and Human Services

List of Devices for Third Party Review

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Database updated June 10, 2024

This page lists devices currently eligible for third-party review under the FDA's 510(k) Third Party Review Program, formally, the Accredited Persons Program. Premarket Notifications ["510(k)'s"] for devices on this list can be submitted to FDA-recognized 3P510K Review Organizations (Accredited Persons) in lieu of FDA. Information on the 510(k) Third Party Review Program, including links to this page and to a list of accredited persons, is available at the 510(k) Third Party Review Program website.

How to use the list of eligible devices

The list has four columns:

  • The first column provides the classification regulation number for each device from Title 21, Code of Federal Regulations (CFR), Parts 862-892. A classification regulation identifies a generic type of device and specifies the regulatory class that fda has assigned to the device.
  • The second and third columns show the classification name for the device from the CFR, and the class of the device, respectively. In the second column, under each classification regulation name, one or more 3-letter product codes appear, along with the device name associated with each product code. Product codes represent specific subsets of devices grouped under the same classification regulation name. Manufacturers should determine the classification of their device at the product code level that most appropriately identifies their device(s).
  • The fourth column provides a link to available standards to assist manufacturers in the preparation-and 3P510k review organizations in the review-of 510(k)s for eligible devices.

Some important exceptions to the list

Please see the 510(k) Third Party Review Program Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations for exceptions to the list.


Ophthalmic

help
Section No. Regulation Name
Product Code-Device Name
Class
Available
Standards
886.1120 Ophthalmic camera.    
  HKI -  Camera, Ophthalmic, Ac-Powered II
  QER -  Camera, Ophthalmic, Slit-Scanning II
886.1220 Corneal electrode.    
  HLZ -  Electrode, Corneal II
886.1300 Afterimage flasher.    
  NJG -  Flasher, Afterimage, Ophthalmic II
886.1360 Visual field laser instrument.    
  HPJ -  Instrument, Visual Field, Laser II
886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.    
  HJK -  Lens, Contact, Polymethylmethacrylate, Diagnostic II
886.1510 Eye movement monitor.    
  HLL -  Monitor, Eye Movement II
  HMC -  Monitor, Eye Movement, Diagnostic II
886.1570 Ophthalmoscope.    
  MYC -  Ophthalmoscope, Laser, Scanning II
886.1630 AC-powered photostimulator.    
  HLX -  Photostimulator, Ac-Powered II
886.1640 Ophthalmic preamplifier.    
  HLT -  Preamplifier, Ac-Powered, Ophthalmic II
  HLW -  Preamplifier, Battery-Powered, Ophthalmic II
886.1670 Ophthalmic isotope uptake probe.    
  HPW -  Probe And Counter, Isotope, For Phosphorus 32 II
886.1850 AC-powered slitlamp biomicroscope.    
  HJO -  Biomicroscope, Slit-Lamp, Ac-Powered II
  MXK -  Device, Analysis, Anterior Segment II
  NQE -  Microscope, Specular II
886.1930 Tonometer and accessories.    
  HKY -  Tonometer, Manual II
  HLA -  Calibrator, Tonometer II
  HPK -  Tonograph II
  NJJ -  Tonometer, Analyzer, Ocular Blood Flow II
886.3400 Keratoprosthesis.    
  MLP -  Keratoprosthesis, Temporary Implant, Surgical Use II
886.4100 Radiofrequency electrosurgical cautery apparatus.    
  HQQ -  Apparatus, Cautery, Radiofrequency, Battery-Powered II
  HQR -  Apparatus, Cautery, Radiofrequency, Ac-Powered II
  NCR -  Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered II
886.4115 Thermal cautery unit.    
  HQO -  Unit, Cautery, Thermal, Ac-Powered II
  HQP -  Unit, Cautery, Thermal, Battery-Powered II
886.4150 Vitreous aspiration and cutting instrument.    
  HKP -  Instrument, Vitreous Aspiration And Cutting, Battery-Powered II
  HQE -  Instrument, Vitreous Aspiration And Cutting, Ac-Powered II
  MLZ -  Vitrectomy, Instrument Cutter II
  MMC -  Dilator, Expansive Iris (Accessory) II
886.4170 Cryophthalmic unit.    
  HPS -  Unit, Cryophthalmic II
  HQA -  Unit, Cryotherapy, Ophthalmic II
  HRN -  Unit, Cryophthalmic, Ac-Powered II
886.4300 Intraocular lens guide.    
  MSS -  Folders And Injectors, Intraocular Lens (Iol) I
  NCE -  Injector, Capsular Tension Ring I
886.4350 Manual ophthalmic surgical instrument.    
  NLA -  Knife, Ophthalmic, Reprocessed I
886.4370 Keratome.    
  HMY -  Keratome, Battery-Powered I
  HNO -  Keratome, Ac-Powered I
  MYD -  Keratome, Water Jet I
  NKY -  Blade, Keratome, Reprocessed I
886.4390 Ophthalmic laser.    
  HQF -  Laser, Ophthalmic II
  LQJ -  Lens, Surgical, Laser, Accesssory, Ophthalmic Laser II
886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy.    
  LXS -  Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla II
886.4610 Ocular pressure applicator.    
  LCC -  Applicator, Ocular Pressure II
886.4670 Phacofragmentation system.    
  HQC -  Unit, Phacofragmentation II
  MUS -  Fluidic, Phacoemulsification/Phacofragmentation II
  MXO -  Laser, System, Phacolysis II
  NKX -  Needle, Phacoemulsification, Reprocessed II
886.4690 Ophthalmic photocoagulator.    
  HQB -  Photocoagulator And Accessories II
886.5100 Ophthalmic beta radiation source.    
  HRL -  Unit, Beta, Radiation, Ophthalmic II
886.5916 Rigid gas permeable contact lens.    
  HQD -  Lens, Contact (Other Material) - Daily II
886.5918 Rigid gas permeable contact lens care products.    
  MRC -  Products, Contact Lens Care, Rigid Gas Permeable II
886.5925 Soft (hydrophilic) contact lens.    
  LPL -  Lenses, Soft Contact, Daily Wear II
  MVN -  Lens, Contact, (Disposable) II
  MZD -  System, In-Office Tinting, Contact Lenses II
  NCZ -  Lens, Contact, For Color Vision Deficiency II
  NIC -  Lens, Contact, For Reading Discomfort II
886.5928 Soft (hydrophilic) contact lens care products.    
  HRC -  Sterilizer, Soft-Lens, Thermal, Battery-Powered II
  HRD -  Sterilizer, Soft-Lens, Thermal, Ac-Powered II
  LPN -  Accessories, Soft Lens Products II
  LRX -  Case, Contact Lens II
  LYL -  Accessories, Solution, Ultrasonic Cleaners For Lenses II

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