Synergeyes, Inc.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Synergeyes, Inc.” (first 2005, latest 2016), across 1 product code in 1 review panel. Median 510(k) review time under this name: 72 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 135 |
| 2013 | 0 | — |
| 2014 | 1 | 72 |
| 2015 | 0 | — |
| 2016 | 2 | 223 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | 11 | 11 |
Review panels
- Ophthalmic (11)
Most recent Synergeyes, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| 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 | 2016-11-15 | 327 |
| K160938 | SynergEyes SiH with Hydra-PEG(petrafocon A hem-larafilcon A) Hybrid Daily Wear Lens | HQD | 2016-08-01 | 119 |
| K142510 | UltraHealth Hybrid Contact Lens for Keratoconus, UltraHealth Flat Cornea Hybrid Contact Lens | HQD | 2014-11-19 | 72 |
| K113586 | SYNERGEYES SIH (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS | HQD | 2012-04-18 | 135 |
| K083921 | SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS | HQD | 2009-05-20 | 140 |
| K081034 | SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS | HQD | 2008-05-30 | 49 |
| K080193 | SYNERGEYES HYBRID CONTACT LENSES-DAILY WEAR | HQD | 2008-03-05 | 40 |
| K061120 | SYNERGEYES (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENSES | HQD | 2006-06-22 | 62 |
| K060102 | SYNERGEYES PS HYBRID CONTACT LENS | HQD | 2006-03-15 | 61 |
| K052675 | SYNERGEYES KC (PAFLUFOCON D HEM-IBERFILCON A) HYBRID CONTACT LENS FOR KERATOCONUS | HQD | 2005-11-30 | 64 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Synergeyes, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Synergeyes, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT00804505: Hybrid SA RGP Center/S-H Skirt Daily Wear 90 Day Multicenter Study (Completed, started 2008-06)
Frequently asked questions
How many FDA 510(k) clearances are listed under Synergeyes, Inc.?
FDA lists 11 510(k) clearances under the applicant name “Synergeyes, Inc.” (first 2005, latest 2016), across 1 product code in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Synergeyes, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Synergeyes, Inc. is 72 days.
Which FDA product codes appear under Synergeyes, Inc.?
The most frequent FDA product codes under this applicant name are HQD (Lens, Contact (Other Material) - Daily, 11).
Next steps
- See all 11 Synergeyes, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HQD, Synergeyes, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.