• 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
-

Database updated: February 7, 2002

See Related 

This page lists devices currently eligible for third-party review under the FDA's Accredited Persons Program. Premarket notifications ["510(k)'s"] for devices on this list can be submitted to FDA-accredited third parties (Accredited Persons) in lieu of FDA. Information on the Accredited Persons Program, including links to this page and to a list of Accredited Persons, is available at the Accredited Persons Inspection Program website.

The following topics are discussed in this introduction to the list of eligible devices:

  • How to use the list of eligible devices
  • Some important exceptions to the list
  • Expansion pilot

How to Use the List of Eligible Devices

The list has five 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 indicates if a device (product code) is included in the expansion pilot, described below, by showing the word "pilot." If this column is blank, the device is eligible for review under the pre-existing program and is not part of the expansion pilot.
  • The fifth column provides a link to device-specific guidance, if available, or to general guidance to assist manufacturers in the preparation-and Accredited Persons in the review-of 510(k)'s for eligible devices. Links are not provided for devices in the expansion pilot; device-specific guidance does not exist for these devices, and special procedures apply to the review of 510(k)'s for these devices by Accredited Persons, as discussed in FDA's January 2001 procedural guidance for the Accredited Persons Program, cited below.
Some Important Exceptions to the List

There are some exceptions that are not reflected in the eligible device list:

  • A device may be eligible even if it does not appear on the list if it is a Class I or Class II device that has been exempted from 510(k) by regulation, but requires a 510(k) because it exceeds the limitations of the exemption (as discussed in FDA's device classification regulations). Devices that are exempt from 510(k) are not shown on the list.
  • A Class II device on the list is ineligible if a 510(k) for the device requires clinical data to demonstrate substantial equivalence. This exception is discussed in FDA's procedural guidance for the Accredited Persons Program, cited below.
  • A device on the list is ineligible if a 510(k) for the device requires multi-Center review (e.g., 510(k)'s for drug/device combination products) or if a Center other than CDRH (e.g., the Center for Biologics Evaluation and Research) has primary responsibility for review.
Expansion Pilot

In an effort to encourage greater use of the Accredited Persons Program, FDA expanded the third party pilot to permit Accredited Persons to review many Class II devices that were not previously eligible. The expanded pilot allows, subject to certain conditions, Accredited Persons to review Class II devices for which there are no device-specific guidance documents. Information on the expansion pilot, including criteria allowing for the review of these Class II devices, can be found in the guidance document entitled Implementation of Third Party Programs Under the FDA Modernization Act of 1997; Final Guidance for Staff, Industry and Third Parties. Accredited Persons and other interested parties should refer to Section II.B., Purpose and Nature of the Program, for the criteria that would allow for the review of the Class II devices in the expansion pilot.


Ophthalmic

Help
Section No. Regulation Name
Product Code-Device Name
Class Pilot
Relevant
Guidance/Standard
886.1120 AC-POWERED OPHTHALMIC CAMERA II  
  HKI -  Camera, Ophthalmic, Ac-Powered   Pilot  
  MMF -  Photorefractor   Pilot  
886.1220 CORNEAL ELECTRODE II  
  HLZ -  Electrode, Corneal   Pilot  
886.1250 EUTHYSCOPE II  
  HMK -  Euthyscope, Ac-Powered   Pilot  
886.1300 AFTER IMAGE FLASHER II  
  NJG -  Flasher, Afterimage, Ophthalmic   Pilot  
886.1360 VISUAL FIELD LASER INSTRUMENT II  
  HPJ -  Instrument, Visual Field, Laser   Pilot  
886.1385 POLYMETHYLMETHACRYLATE DIAGNOSTIC CONTACT LENS II  
  HJK -  Lens, Contact, Polymethylmethacrylate, Diagnostic   Pilot  
886.1510 EYE MOVEMENT MONITOR II  
  HLL -  Monitor, Eye Movement   Pilot  
  HMC -  Monitor, Eye Movement, Diagnostic   Pilot  
886.1570 OPHTHALMOSCOPE - 2 CLASSES II  
  HLI -  Ophthalmoscope, Ac-Powered      
  HLJ -  Ophthalmoscope, Battery-Powered      
  MYC -  Ophthalmoscope,Laser,Scanning      
886.1630 AC-POWERED PHOTOSTIMULATOR II  
  HLX -  Photostimulator, Ac-Powered   Pilot  
886.1640 OPHTHALMIC PREAMPLIFIER II  
  HLT -  Preamplifier, Ac-Powered, Ophthalmic   Pilot  
  HLW -  Preamplifier, Battery-Powered, Ophthalmic   Pilot  
886.1670 OPHTHALMIC ISOTOPE UPTAKE PROBE II  
  HPW -  Probe And Counter, Isotope, For Phosphorus 32   Pilot  
886.1780 RETINOSCOPE II  
  HKL -  Retinoscope, Ac-Powered      
886.1850 AC-POWERED SLIT-LAMP BIOMICROSCOPE II  
  HJO -  Biomicroscope, Slit-Lamp, Ac-Powered      
  MXK -  Device,Analysis,Anterior Segment   Pilot  
  NQE -  Microscope, Specular   Pilot  
886.1930 TONOMETER AND ACCESSORIES II  
  HKX -  Tonometer, Ac-Powered   Pilot  
  HKY -  Tonometer, Manual   Pilot  
  HLA -  Calibrator, Tonometer   Pilot  
  HPK -  Tonograph   Pilot  
  NJJ -  Tonometer, Analyzer, Ocular Blood Flow   Pilot  
886.1945 TRANSILLUMINATOR II  
  HJM -  Transilluminator, Ac-Powered   Pilot  
886.3400 KERATOPROSTHESIS II  
  MLP -  Keratoprosthesis, Temporary Implant, Surgical Use      
886.4070 POWERED CORNEAL BURR I  
 General Guidance
  HLD -  Engine, Trephine, Accessories, Gas-Powered      
  HOG -  Burr, Corneal, Battery-Powered      
  HQS -  Burr, Corneal, Ac-Powered      
  HRF -  Engine, Trephine, Accessories, Battery-Powered      
  HRG -  Engine, Trephine, Accessories, Ac-Powered      
886.4100 RADIOFREQUENCY CAUTERY APPARATUS II  
  HQQ -  Apparatus, Cautery, Radiofrequency, Battery-Powered   Pilot  
  HQR -  Apparatus, Cautery, Radiofrequency, Ac-Powered   Pilot  
  NCR -  Apparatus, Cutting, Radiofrequency, Electrosurgical, Battery-Powered   Pilot  
886.4115 THERMAL CAUTERY UNIT II  
  HQO -  Unit, Cautery, Thermal, Ac-Powered   Pilot  
  HQP -  Unit, Cautery, Thermal, Battery-Powered   Pilot  
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)      
  MSR -  Tubing, Replacement, Phacofragmentation Unit   Pilot  
886.4170 CRYOPHTHALMIC UNIT II  
  HPS -  Unit, Cryophthalmic   Pilot  
  HQA -  Unit, Cryotherapy, Ophthalmic   Pilot  
  HRN -  Unit, Cryophthalmic, Ac-Powered   Pilot  
886.4250 OPHTHALMIC ELECTROLYSIS UNIT II  
  HRO -  Unit, Electrolysis, Ac-Powered, Ophthalmic   Pilot  
886.4300 INTRAOCULAR LENS GUIDE I  
 General Guidance
  KYB -  Lens, Guide, Intraocular      
  MSS -  Folders And Injectors, Intraocular Lens (Iol)      
  NCE -  Injector, Capsular Tension Ring      
886.4335 OPERATING HEADLAMP II  
  FCT -  Headlight, Fiberoptic Focusing   Pilot  
  FSR -  Light, Headband, Surgical   Pilot  
  HPQ -  Headlamp, Operating, Ac-Powered   Pilot  
886.4370 KERATOME I  
  HMY -  Keratome, Battery-Powered      
  HNO -  Keratome, Ac-Powered      
  MYD -  Keratome,Water Jet      
886.4390 OPHTHALMIC LASER II  
  HQF -  Laser, Ophthalmic      
  LQJ -  Lens, Surgical, Laser, Accesssory, Ophthalmic Laser      
886.4392 ND:YAG LASER FOR POSTERIOR CAPSULOTOMY II  
  LXS -  Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla      
886.4400 ELECTRONIC METAL LOCATOR II  
  HPM -  Locator, Metal, Electronic   Pilot  
886.4440 AC-POWERED MAGNET II  
  HPO -  Magnet, Ac-Powered   Pilot  
886.4610 OCULAR PRESSURE APPLICATOR II  
  LCC -  Applicator, Ocular Pressure   Pilot  
886.4670 PHACOFRAGMENTATION SYSTEM II  
  HTML Guidance file for PHACOFRAGMENTATION SYSTEM (21CFR886.4670)
  HQC -  Unit, Phacofragmentation      
  MUS -  Fluidic, Phacoemulsification/Phacofragmentation   Pilot  
  MXO -  Laser,System,Phacolysis   Pilot  
886.4690 OPHTHALMIC PHOTOCOAGULATOR II  
  HQB -  Photocoagulator And Accessories   Pilot  
886.4790 OPHTHALMIC SPONGE II  
  HOZ -  Sponge, Ophthalmic   Pilot  
886.5100 OPHTHALMIC BETA RADIATION SOURCE II  
  HRL -  Unit, Beta, Radiation, Ophthalmic   Pilot  
886.5916 RIGID GAS PERMEABLE CONTACT LENS II  
  HQD -  Lens, Contact (Other Material) - Daily      
886.5918 RIGID GAS PERMEABLE CONTACT LENS CARE PRODUCTS II  
  HTML Guidance file for RIGID GAS PERMEABLE CONTACT LENS CARE PRODUCTS (21CFR886.5918)
  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      
886.5928 SOFT (HYDROPHYLIC) CONTACT LENS CARE PRODUCTS II  
  HTML Guidance file for SOFT (HYDROPHYLIC) CONTACT LENS CARE PRODUCTS (21CFR886.5928)
  HRC -  Sterilizer, Soft-Lens, Thermal, Battery-Powered   Pilot  
  HRD -  Sterilizer, Soft-Lens, Thermal, Ac-Powered   Pilot  
  LPN -  Accessories, Soft Lens Products      
  LRX -  Case, Contact Lens      
  LYL -  Accessories, Solution, Ultrasonic Cleaners For Lenses      

-
-