Data / Medical devices / United States / Acculens, Inc.
Acculens, Inc.: FDA-registered device maker in Golden, CO, United States, 1 510(k) clearance
Acculens, Inc. is registered with the FDA (registration 1720959) in Golden, CO, United States. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated June 16, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1720959
- Address
- 13301 W 43rd Dr Unit 4, Golden, CO, United States, 80403
- Owner or operator
- AccuLens, Inc. (10057998)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- June 23, 2018
- Registered through
- 2026
- Brand names listed
- Hyper GP (tisilfocon A) Daily Wear Contact Lens, NewVision, Optimum Gp, Optimum Gp Modification, Optimum Gp Ok, Optimum Gp with Hpt, Optimum Hr-1.51 and Hr-1.53, Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact (Orthokeratology) | MUW | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Lens, Contact (Other Material) - Daily | HQD | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 16, 2023 | K230910 | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens | HQD | Substantially Equivalent | Acculens, Inc. | accessdata.fda.gov |
Compare with other makers
Updated June 16, 2023. 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.