• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

List of Devices for Third Party Review

  • Print
  • Share
  • E-mail
-
see related
Database updated November 29, 2021

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. II  
  HKI -  Camera, Ophthalmic, Ac-Powered  
  QER -  Camera, Ophthalmic, Slit-Scanning  
886.1220 Corneal electrode. II  
  HLZ -  Electrode, Corneal  
886.1300 Afterimage flasher. II  
  NJG -  Flasher, Afterimage, Ophthalmic  
886.1360 Visual field laser instrument. II  
  HPJ -  Instrument, Visual Field, Laser  
886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens. II  
  HJK -  Lens, Contact, Polymethylmethacrylate, Diagnostic  
886.1510 Eye movement monitor. II  
  HLL -  Monitor, Eye Movement  
  HMC -  Monitor, Eye Movement, Diagnostic  
886.1570 Ophthalmoscope. II  
  MYC -  Ophthalmoscope, Laser, Scanning  
886.1630 AC-powered photostimulator. II  
  HLX -  Photostimulator, Ac-Powered  
886.1640 Ophthalmic preamplifier. II  
  HLT -  Preamplifier, Ac-Powered, Ophthalmic  
  HLW -  Preamplifier, Battery-Powered, Ophthalmic  
886.1670 Ophthalmic isotope uptake probe. II  
  HPW -  Probe And Counter, Isotope, For Phosphorus 32  
886.1850 AC-powered slitlamp biomicroscope. II  
  HJO -  Biomicroscope, Slit-Lamp, Ac-Powered  
  MXK -  Device, Analysis, Anterior Segment  
  NQE -  Microscope, Specular  
886.1930 Tonometer and accessories. II  
  HKY -  Tonometer, Manual  
  HLA -  Calibrator, Tonometer  
  HPK -  Tonograph  
  NJJ -  Tonometer, Analyzer, Ocular Blood Flow  
886.3400 Keratoprosthesis. II  
  MLP -  Keratoprosthesis, Temporary Implant, Surgical Use  
886.4100 Radiofrequency electrosurgical cautery apparatus. II  
  HQQ -  Apparatus, Cautery, Radiofrequency, Battery-Powered  
  HQR -  Apparatus, Cautery, Radiofrequency, Ac-Powered  
  NCR -  Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered  
886.4115 Thermal cautery unit. II  
  HQO -  Unit, Cautery, Thermal, Ac-Powered  
  HQP -  Unit, Cautery, Thermal, Battery-Powered  
886.4150 Vitreous aspiration and cutting instrument. II  
  HKP -  Instrument, Vitreous Aspiration And Cutting, Battery-Powered  
  HQE -  Instrument, Vitreous Aspiration And Cutting, Ac-Powered  
  MLZ -  Vitrectomy, Instrument Cutter  
  MMC -  Dilator, Expansive Iris (Accessory)  
886.4170 Cryophthalmic unit. II  
  HPS -  Unit, Cryophthalmic  
  HQA -  Unit, Cryotherapy, Ophthalmic  
  HRN -  Unit, Cryophthalmic, Ac-Powered  
886.4300 Intraocular lens guide. I  
  MSS -  Folders And Injectors, Intraocular Lens (Iol)  
  NCE -  Injector, Capsular Tension Ring  
886.4350 Manual ophthalmic surgical instrument. I  
  NLA -  Knife, Ophthalmic, Reprocessed  
886.4370 Keratome. I  
  HMY -  Keratome, Battery-Powered  
  HNO -  Keratome, Ac-Powered  
  MYD -  Keratome, Water Jet  
  NKY -  Blade, Keratome, Reprocessed  
886.4390 Ophthalmic laser. II  
  HQF -  Laser, Ophthalmic  
  LQJ -  Lens, Surgical, Laser, Accesssory, Ophthalmic Laser  
886.4392 Nd:YAG laser for posterior capsulotomy and peripheral iridotomy. II  
  LXS -  Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla  
886.4610 Ocular pressure applicator. II  
  LCC -  Applicator, Ocular Pressure  
886.4670 Phacofragmentation system. II  
  HQC -  Unit, Phacofragmentation  
  MUS -  Fluidic, Phacoemulsification/Phacofragmentation  
  MXO -  Laser, System, Phacolysis  
  NKX -  Needle, Phacoemulsification, Reprocessed  
886.4690 Ophthalmic photocoagulator. II  
  HQB -  Photocoagulator And Accessories  
886.5100 Ophthalmic beta radiation source. II  
  HRL -  Unit, Beta, Radiation, Ophthalmic  
886.5916 Rigid gas permeable contact lens. II  
  HQD -  Lens, Contact (Other Material) - Daily  
886.5918 Rigid gas permeable contact lens care products. II  
  MRC -  Products, Contact Lens Care, Rigid Gas Permeable  
886.5925 Soft (hydrophilic) contact lens. II  
  LPL -  Lenses, Soft Contact, Daily Wear  
  MVN -  Lens, Contact, (Disposable)  
  MZD -  System, In-Office Tinting, Contact Lenses  
  NCZ -  Lens, Contact, For Color Vision Deficiency  
  NIC -  Lens, Contact, For Reading Discomfort  
886.5928 Soft (hydrophilic) contact lens care products. II  
  HRC -  Sterilizer, Soft-Lens, Thermal, Battery-Powered  
  HRD -  Sterilizer, Soft-Lens, Thermal, Ac-Powered  
  LPN -  Accessories, Soft Lens Products  
  LRX -  Case, Contact Lens  
  LYL -  Accessories, Solution, Ultrasonic Cleaners For Lenses  

-
-