Oculus Innovative Sciences: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Oculus Innovative Sciences” (first 2005, latest 2017), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 122 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 | 0 | — |
| 2013 | 1 | 162 |
| 2014 | 2 | 98 |
| 2015 | 3 | 122 |
| 2016 | 2 | 124 |
| 2017 | 1 | 227 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Oculus Innovative Sciences took a median 227 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 228 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FRO | Dressing, Wound, Drug | 14 | 14 |
| KJJ | Cleanser, Root Canal | 1 | 1 |
| PFP | Silicone Hydrogel For Scar Management | 1 | 1 |
Review panels
- General and Plastic Surgery (15)
- Dental (1)
Most recent Oculus Innovative Sciences 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K162217 | LOYON | FRO | 2017-03-23 | 227 |
| K161034 | Microcyn Plus Wound Care Solution | FRO | 2016-08-19 | 128 |
| K153648 | Microcyn Plus Skin and Wound Hydrogel | FRO | 2016-04-19 | 120 |
| K152945 | Alevicyn SG Antipruritic Gel | FRO | 2015-12-15 | 70 |
| K152055 | Ceramax Skin Barrier Cream | FRO | 2015-11-23 | 122 |
| K143590 | Alevicyn SG Antipruritic Gel | FRO | 2015-06-04 | 168 |
| K141352 | ENDOCYN ROOT CANAL IRRIGATION SOLUTION | KJJ | 2014-08-18 | 87 |
| K141012 | HYDROCLEANSE WOUND CARE SOLUTION | FRO | 2014-08-08 | 109 |
| K131672 | MICROCYN SCAR MANAGEMENT HYDROGEL | PFP | 2013-11-15 | 162 |
| K102945 | PEDIACYN ATOPIC DERMATITIS HYDROGEL | FRO | 2011-02-02 | 121 |
6 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 3 recall events; 0 initiated in the last five years. Most recent: 2016-11-21.
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 Oculus Innovative Sciences is the lead sponsor of 1 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT01232985: Efficacy and Tolerability Study of Device, RD047-26 for the Treatment of Mild to Moderate Atopic Dermatitis in Adults (Completed, started 2010-10)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Oculus Optikgerate GmbH (6 510(k)s)
- Oculus Optikgeräte GmbH (2 510(k)s)
- Oculus Private Limited (2 510(k)s)
- Oculus America (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oculus Innovative Sciences?
FDA lists 16 510(k) clearances under the applicant name “Oculus Innovative Sciences” (first 2005, latest 2017), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Oculus Innovative Sciences?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oculus Innovative Sciences is 122 days.
Which FDA product codes appear under Oculus Innovative Sciences?
The most frequent FDA product codes under this applicant name are FRO (Dressing, Wound, Drug, 14); KJJ (Cleanser, Root Canal, 1); PFP (Silicone Hydrogel For Scar Management, 1).
Next steps
- See all 16 Oculus Innovative Sciences clearances with predicates and recalls
- Run predicate analysis for product code FRO, Oculus Innovative Sciences'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.