Data / Medical devices / Lens, Contact, Orthokeratology, Overnight
Lens, Contact, Orthokeratology, Overnight (NUU): 17 FDA-registered makers in 6 countries
17 establishments in 6 countries are registered with the FDA to make Lens, Contact, Orthokeratology, Overnight (product code NUU, Class 3, 21 CFR 886.5916). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 3, 2026.
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- Product code
- NUU
- Device class
- 3
- Regulation
- 886.5916
- Medical specialty
- Ophthalmic
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Japan | 3 |
| Canada | 2 |
| United Kingdom | 1 |
| China | 1 |
| Netherlands | 1 |
Makers of Lens, Contact, Orthokeratology, Overnight
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Advanced Vision Technologies | Lakewood, CO, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Bausch & Lomb Incorporated | Wilmington, MA, United States | Manufacturer, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Contamac Ltd. | Essex Uk, United Kingdom | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Contex, Incorporated | Sherman Oaks, CA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Euclid Vision Corporation | Sterling, VA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Paragon Vision Sciences, Inc. | Gilbert, AZ, United States | Complaint file establishment, Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Tianjin Mastervision Technology Co., Ltd. | Wuqing District Tianjin, China | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Visionary Contact Lens, Inc. | Anaheim, CA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Aurora GP Lab Inc | Goodyear, AZ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blanchard Vision Corp. | SHERBROOKE Quebec, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cler Vision Inc. | Riverside, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Menicon B.V. | Emmen Drenthe, Netherlands | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Menicon Co., Ltd. Techno-station | Kakamigahara Gifu, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Menicon Co., Ltd., R&D Center | Kasugai Aichi, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Menicon Nect Co., Ltd., Gujo Plant | Gujo Gifu, Japan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Optik K & R Inc. | Toronto Ontario, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| X-Cel Specialty Contacts | Duluth, GA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.