Data / Medical devices / Mexico / Oculus Technologies of Mexico, S.A de C.V.
Oculus Technologies of Mexico, S.A de C.V.: FDA-registered device maker in Zapopan Jalisco, Mexico, 15 510(k) clearances
Oculus Technologies of Mexico, S.A de C.V. is registered with the FDA (registration 3007244484) in Zapopan Jalisco, Mexico. It lists 3 device types. The FDA files 15 510(k) clearances under its listings, the newest dated June 24, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007244484
- Address
- Industria Vidriera 81 Fraccionamiento Industrial Zapopan Norte, Zapopan Jalisco, Mexico, 45130
- Owner or operator
- Sonoma Pharmaceuticals Inc. (9063175)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 2, 2009
- Registered through
- 2027
- Brand names listed
- A+D Advanced Dermatitis Care Spray Hydrogel, A+D Antimicrobial Hydrogel Spray, A+D Cleansing & Skin Support Spray, A+D Gentle Face Relief, Advanced Scar & Wound Hydrogel, Alevicyn SG, Aquanil AD Recovery Gel, Aquanil AD Repair Mist and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cleanser, Root Canal | KJJ | U | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Dressing, Wound, Drug | FRO | U | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Silicone Hydrogel For Scar Management | PFP | 1 | 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 24, 2026 | K261023 | Microdacyn Wound Irrigation Solution | FRO | Substantially Equivalent | Sonoma Pharmaceuticals, Inc. | accessdata.fda.gov |
| September 13, 2024 | K233399 | Microdacyn Wound Care Solution | FRO | Substantially Equivalent | Sonoma Pharmaceuticals, Inc. | accessdata.fda.gov |
| December 1, 2017 | K171935 | Alevicyn SG Antimicrobial Gel | FRO | Substantially Equivalent | Sonoma Pharmaceuticals, Inc. | accessdata.fda.gov |
| November 21, 2017 | K172622 | Microcyn Antimicrobial Skin and Wound Cleanser | FRO | Substantially Equivalent | Sonoma Pharmaceuticals | accessdata.fda.gov |
| November 15, 2017 | K172851 | Microcyn Plus Antimicrobial Wound Care Solution | FRO | Substantially Equivalent | Sonoma Pharmaceuticals, Inc. | accessdata.fda.gov |
| July 26, 2017 | K171727 | Hydrocleanse Antimicrobial Skin and Wound Care Solution | FRO | Substantially Equivalent | Sonoma Pharmaceuticals | accessdata.fda.gov |
| March 23, 2017 | K162217 | LOYON | FRO | Substantially Equivalent | Oculus Innovative Sciences | accessdata.fda.gov |
| April 19, 2016 | K153648 | Microcyn Plus Skin and Wound Hydrogel | FRO | Substantially Equivalent | Oculus Innovative Sciences | accessdata.fda.gov |
| December 15, 2015 | K152945 | Alevicyn SG Antipruritic Gel | FRO | Substantially Equivalent | Oculus Innovative Sciences | accessdata.fda.gov |
| June 4, 2015 | K143590 | Alevicyn SG Antipruritic Gel | FRO | Substantially Equivalent | Oculus Innovative Sciences | accessdata.fda.gov |
| August 18, 2014 | K141352 | ENDOCYN ROOT CANAL IRRIGATION SOLUTION | KJJ | Substantially Equivalent | Oculus Innovative Sciences | accessdata.fda.gov |
| August 8, 2014 | K141012 | HYDROCLEANSE WOUND CARE SOLUTION | FRO | Substantially Equivalent | Oculus Innovative Sciences | accessdata.fda.gov |
| November 15, 2013 | K131672 | MICROCYN SCAR MANAGEMENT HYDROGEL | PFP | Substantially Equivalent | Oculus Innovative Sciences | accessdata.fda.gov |
| March 8, 2010 | K093585 | MICROCYN SKIN AND WOUND HYDROGEL | FRO | Substantially Equivalent | Oculus Innovative Sciences, Inc. | accessdata.fda.gov |
| June 2, 2009 | K090206 | OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER | FRO | Substantially Equivalent | Oculus Innovative Sciences, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 27, 2026 | 98959 | Class II | Ongoing | PhaseOne Antimicrobial Solution, Model/Catalog Number: 15050 | The recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material incompatibility between the product solution and the stainless steel spring and may result in visible discoloration and the presence of trace levels of metallic elements (including iron, chromium, and nickel) in th | accessdata.fda.gov |
Compare with other makers
- All makers of Dressing, Wound, Drug
- All makers of Silicone Hydrogel For Scar Management
- All makers of Cleanser, Root Canal
Updated June 24, 2026. 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.