Data / Medical devices / United States / Synergeyes, Inc.
Synergeyes, Inc.: FDA-registered device maker in Carlsbad, CA, United States, 2 510(k) clearances
Synergeyes, Inc. is registered with the FDA (registration 3005087645) in Carlsbad, CA, United States. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated November 15, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005087645
- Address
- 2232 Rutherford Rd, Carlsbad, CA, United States, 92008
- Owner or operator
- COOPERVISION, INC. (9929062)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- December 19, 2022
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact (Other Material) - Daily | HQD | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| November 15, 2016 | K153714 | SynergEyes A&M (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes KC (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes PS (paflufocon D hem-iberfilcon A) Hybrid Daily Wear Contact Lens, SynergEyes SiH (petrafocon A hem-larafilcon A) Hybrid Daily Wear Contact Lens, SynergEyes UltraHealth for Keratoconus (petrafocon A hem-larafilcon A) Hybrid Daily Wear Co | HQD | Substantially Equivalent | Synergeyes, Inc. | accessdata.fda.gov |
| August 1, 2016 | K160938 | SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens | HQD | Substantially Equivalent | Synergeyes, Inc. | accessdata.fda.gov |
Compare with other makers
Updated November 15, 2016. 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.