Synergeyes, Inc.: FDA clearances and approvals
Synergeyes, Inc. has 11 FDA 510(k) clearances (first 2005, latest 2016), across 1 product code in 1 review panel. Median 510(k) review time: 72 days. It is the industry lead sponsor of 1 device clinical trial on ClinicalTrials.gov.
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 company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Synergeyes, Inc. is the industry 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 does Synergeyes, Inc. have?
Synergeyes, Inc. has 11 FDA 510(k) clearances (first 2005, latest 2016), across 1 product code in 1 review panel.
How long does FDA take to clear Synergeyes, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Synergeyes, Inc.'s cleared 510(k)s is 72 days.
What devices does Synergeyes, Inc. make?
Its most frequent FDA product codes are HQD (Lens, Contact (Other Material) - Daily, 11).
Has Synergeyes, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Synergeyes, Inc. Related entities may recall under other names.
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. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.