OCULAR INSTRUMENTS, INC.
Registration 3014865FEI 3014865BELLEVUE, WA
Owner/operator: OCULAR INSTRUMENTS
- Manufacture Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 43
- Added, last 12 months
- 0
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
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 processWait 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 processRenew 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 listingReview 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 43
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| MLP | OLTCW-Landers Wide Field Corneal WindowKeratoprosthesis, Temporary Implant, Surgical Use | Class 2 | 21 CFR 886.3400 | K910828 |
| MLP | OCTK-6.5-Cobo Temporary Keratoprothesis 6.5mmKeratoprosthesis, Temporary Implant, Surgical Use | Class 2 | 21 CFR 886.3400 | K895013 |
| HJK | OMRA-HM-2-Mainster High Magnification Laser Lens NMRLens, Contact, Polymethylmethacrylate, Diagnostic | Class 2 | 21 CFR 886.1385 | K912366 |
| HJK | OLV-9-Woldoff Prismatic Biconcave Vitrectomy LensLens, Contact, Polymethylmethacrylate, Diagnostic | Class 2 | 21 CFR 886.1385 | K894421 |
| HJK | OAIA-Abraham Iridectomy Laser LensLens, Contact, Polymethylmethacrylate, Diagnostic | Class 2 | 21 CFR 886.1385 | K863027 |
| HJK | OHBG-2-Hoskins-Barkan Goniotomy Premature Lens 9mm O.D.Lens, Contact, Polymethylmethacrylate, Diagnostic | Class 2 | 21 CFR 886.1385 | K875114 |
| HJK | ORNSA-Ritch Nylon Suture Laser LensLens, Contact, Polymethylmethacrylate, Diagnostic | Class 2 | 21 CFR 886.1385 | K933264 |
| HJK | OYFA-Yannuzzi Fundus Laser LensLens, Contact, Polymethylmethacrylate, Diagnostic | Class 2 | 21 CFR 886.1385 | K864304 |
| HJK | OHSA-Hoskins Nylon Suture Laser LensLens, Contact, Polymethylmethacrylate, Diagnostic | Class 2 | 21 CFR 886.1385 | K862728 |
| HJK | OPY-18-Peyman Wide Field Yag Laser Lens 18mmLens, Contact, Polymethylmethacrylate, Diagnostic | Class 2 | 21 CFR 886.1385 | K872855 |
| HJK | OJK-2S-Vitreolysis Two Lens SetLens, Contact, Polymethylmethacrylate, Diagnostic | Class 2 | 21 CFR 886.1385 | K871450 |
| HJK | OFVI-Flat Vitrectomy Lens w/Infusion HandleLens, Contact, Polymethylmethacrylate, Diagnostic | Class 2 | 21 CFR 886.1385 | K864418 |
and 31 more on your full dossier
What changed
Nothing added in the last twelve months, and no change seen on the record yet.