Device Desk

Private service · Not FDA

FDA device establishment · Lake Forest, CA

This page shows the yearly renewal for this site, from FDA’s public record.

Device Desk is a private service. We are not FDA. We never file or pay for you.

Renewal dossierDD-3013436538As of September 30, 2026

RAY VISION INC.

Registration 3013436538FEI 3013436538Lake Forest, CA

Owner/operator: Ray Vision Inc

  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

Renewal due by December 31, 2026

Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.

90days left in the window

The 2026 window

  1. Oct 1Window opens91 days left
  2. Nov 3Where you stand58 days left
  3. Dec 1Our pay-by date30 days left
  4. Dec 15Two weeks left16 days left
  5. Dec 23Holiday week8 days left
  6. Dec 29Two days left2 days left
  7. Dec 31Window closes0 days left
an email on that date our pay-by date to December 31
FDA fee, FY2027
$13,785
Our pay-by suggestion
Dec 1
Listed devices
35
Added, last 12 months
18

FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page

The steps, in order

  1. Pay FDA's annual feeYou

    Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.

    FDA: registration and listing payment process

  2. Wait for the payment confirmation numberYou

    FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.

    FDA: registration and listing payment process

  3. Renew the registration in FDA's systemYou

    Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.

    FDA: device registration and listing

  4. Review every listingYou

    In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.

    FDA: device registration and listing

Every listed device 35

CodeDeviceClassRegulationPremarket
PUERay Vision Slit Lamp MicroscopeBiomicroscope, Slit-Lamp, Ac-Powered, ExemptClass 221 CFR 886.1850—
PJZRay Vision Digital Camera/Imaging SystemCamera, Ophthalmic, General-UseClass 221 CFR 886.1120—
HLIRay Vision Ophthalmoscope, ac-poweredOphthalmoscope, Ac-PoweredAdded May 26, 2026Class 221 CFR 886.1570—
HLJRay Vision Ophthalmoscope, battery-poweredOphthalmoscope, Battery-PoweredAdded May 26, 2026Class 221 CFR 886.1570—
MSGRay Vision Hand-held OphthalmoscopesOphthalmoscopes, Replacement Batteries, Hand-HeldAdded May 26, 2026Class 221 CFR 886.1570—
MMFRay Vision Vision ScreenerPhotorefractorAdded May 26, 2026Class 221 CFR 886.1120—
HKLRay Vision RetinoscopeRetinoscope, Ac-PoweredAdded May 26, 2026Class 221 CFR 886.1780—
IYORay Vision Ultrasound BiomicroscopeSystem, Imaging, Pulsed Echo, UltrasonicAdded May 27, 2026Class 221 CFR 892.1560K213070
IYORay Vision Ultrasonic Biometer for OphthalmologySystem, Imaging, Pulsed Echo, UltrasonicAdded May 27, 2026Class 221 CFR 892.1560K121243
IYORay Vision Ultrasonic A/B Scanner for OphthalmologySystem, Imaging, Pulsed Echo, UltrasonicAdded May 27, 2026Class 221 CFR 892.1560K152318
ITXRay Vision Ultrasonic Biometer for OphthalmologyTransducer, Ultrasonic, DiagnosticAdded May 27, 2026Class 221 CFR 892.1570K121243
ITXRay Vision Ultrasound BiomicroscopeTransducer, Ultrasonic, DiagnosticAdded May 27, 2026Class 221 CFR 892.1570K213070

and 23 more on your full dossier

What changed

  • May 26, 2026Listing added: HLI — Ray Vision Ophthalmoscope, ac-powered
  • May 26, 2026Listing added: HLJ — Ray Vision Ophthalmoscope, battery-powered
  • May 26, 2026Listing added: MSG — Ray Vision Hand-held Ophthalmoscopes
  • May 26, 2026Listing added: MMF — Ray Vision Vision Screener
  • May 26, 2026Listing added: HKL — Ray Vision Retinoscope
  • May 27, 2026Listing added: IYO — Ray Vision Ultrasound Biomicroscope (K213070)
  • May 27, 2026Listing added: IYO — Ray Vision Ultrasonic Biometer for Ophthalmology (K121243)
  • May 27, 2026Listing added: IYO — Ray Vision Ultrasonic A/B Scanner for Ophthalmology (K152318)
  • May 27, 2026Listing added: ITX — Ray Vision Ultrasonic Biometer for Ophthalmology (K121243)
  • May 27, 2026Listing added: ITX — Ray Vision Ultrasound Biomicroscope (K213070)
  • May 27, 2026Listing added: ITX — Ray Vision Ultrasonic A/B Scanner for Ophthalmology (K152318)
  • May 26, 2026Listing added: HPB — Ray Vision Trial Lens Clip Set
  • May 26, 2026Listing added: HLS — Ray Vision Exophthalmometer
  • May 26, 2026Listing added: HOO — Ray Vision Perimeter
  • May 26, 2026Listing added: HPT — Ray Vision Perimeter
  • May 26, 2026Listing added: HON — Ray Vision Perimeter
  • May 26, 2026Listing added: HKW — Ray Vision Prism Bar
  • May 26, 2026Listing added: HOR — Ray Vision Cross Cylinder
Data provided by the U.S. Food and Drug Administration (https://open.fda.gov). FDA does not endorse Device Desk.FDA’s own record is always the authority.

How we got this date

  1. FDA asks every device site to renew its registration each year.
  2. The renewal window runs from October 1, 2026 to December 31, 2026.
  3. A renewal in this window covers 2027.
  4. The rule is 21 CFR 807.22(b).

FDA’s record shows this registration runs through 2026.

We read this from FDA’s public record on September 30, 2026.

Read FDA’s page on registration

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Keep this desk: $249 a year

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Renews each year until you cancel. Cancel any time from your account.

Is this right?

We copy this from FDA’s public record. FDA’s own record always wins. A listing missing here does not prove anything about FDA’s record.

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