Sonoma Pharmaceuticals, Inc.
Boulder, CO, US
Sonoma Pharmaceuticals, Inc. appears in FDA device records in Boulder, CO. FDA records list 24 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 6 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Sonoma Pharmaceuticals, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Oculus Innovative Sciences, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 24 510(k) clearances for Sonoma Pharmaceuticals, Inc. between 2005 and 2026. The busiest year on record is 2017, with 5. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2006 | 1 |
| 2009 | 2 |
| 2010 | 1 |
| 2011 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 3 |
| 2016 | 2 |
| 2017 | 5 |
| 2018 | 1 |
| 2024 | 2 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261023 | Microdacyn Wound Irrigation Solution | FRO | Substantially Equivalent | |
| K240510 | Microdacyn Hydrogel | FRO | Substantially Equivalent | |
| K233399 | Microdacyn Wound Care Solution | FRO | Substantially Equivalent | |
| K173896 | Microcyn Antimicrobial Hydrogel | FRO | Substantially Equivalent | |
| K171935 | Alevicyn SG Antimicrobial Gel | FRO | Substantially Equivalent | |
| K172622 | Microcyn Antimicrobial Skin and Wound Cleanser | FRO | Substantially Equivalent | |
| K172851 | Microcyn Plus Antimicrobial Wound Care Solution | FRO | Substantially Equivalent | |
| K171727 | Hydrocleanse Antimicrobial Skin and Wound Care Solution | FRO | Substantially Equivalent | |
| K162217 | LOYON | FRO | Substantially Equivalent | |
| K161034 | Microcyn Plus Wound Care Solution | FRO | Substantially Equivalent | |
| K153648 | Microcyn Plus Skin and Wound Hydrogel | FRO | Substantially Equivalent | |
| K152945 | Alevicyn SG Antipruritic Gel | FRO | Substantially Equivalent | |
| K152055 | Ceramax Skin Barrier Cream | FRO | Substantially Equivalent | |
| K143590 | Alevicyn SG Antipruritic Gel | FRO | Substantially Equivalent | |
| K141352 | ENDOCYN ROOT CANAL IRRIGATION SOLUTION | KJJ | Substantially Equivalent | |
| K141012 | HYDROCLEANSE WOUND CARE SOLUTION | FRO | Substantially Equivalent | |
| K131672 | MICROCYN SCAR MANAGEMENT HYDROGEL | PFP | Substantially Equivalent | |
| K102945 | PEDIACYN ATOPIC DERMATITIS HYDROGEL | FRO | Substantially Equivalent | |
| K093585 | MICROCYN SKIN AND WOUND HYDROGEL | FRO | Substantially Equivalent | |
| K090206 | OCULUS PURACYN ANTIMICROBIAL SKIN AND WOUND CLEANSER | FRO | Substantially Equivalent | |
| K090725 | OCULUS MICROCYN WOUND GEL | FRO | Substantially Equivalent | |
| K060113 | DERMACYN WOUND CARE | FRO | Substantially Equivalent | |
| K042729 | DERMACYN WOUND IRRIGATION | FRO | Substantially Equivalent | |
| K041161 | MICROCYN WOUND CARE DRESSING | FRO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004554409 | 3004554409 | Sonoma Pharmaceuticals, Inc. | 5445 Conestoga Ct Ste 150, Boulder, CO 80301 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0763-2017 | Ceramax Skin Barrier Cream: NET WT 0.1 OZ (3 g professional sample - not for retail sale) Under the supervision of a health care professional, Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment. General and Plastic Surgery: Ceramax is intended to be used as a topical skin care preparation to relieve and to manage the burning and itching associated with various dermatoses including atopic dermatitis, irritant contact dermatitis, radiation dermatitis, and other dry skin conditions, by maintaining a moist wound and skin environment. | Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product. | Class II | Terminated | |
| Z-0890-2013 | Atrapro Antipruritic Hydrogel, 1.5 oz gel tube, 4 Net wt/ 1.5 oz.. RX only, Professional Sample, Not for Sale. Pre-printed tube: MS31071, Shelf carton: PL51091-08 Atrapro Antipruritic HydroGel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including radiation dermatitis and atopic dermatitis. | Out of specification result - stability test failure of free available chlorine (FAC) which functions as a preservative for the hydrogel. The 13 month test result obtained was 4 ppm FAC and the stability specification is >10 ppm FAC. | Class II | Terminated | |
| Z-0451-2012 | Microcyn Dermatology HydroGel, Spray , 4 oz and 1.76 oz. Provided Pain Relief, Relieve Itch, Reduces symptoms of inflammation due to irritation, Provide a protective shield against contamination. Antibiotic-free, steroid-free and biodegradable.. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by health care professionals in management of wounds including itch and pain relief associated with dermal irritation, sore, injuries and ulcers or dermal tissue. Microcyn Skin and Wound hydrogel is intended for use on first and second degree burns, excluding wounds such as leg ulcers, pressure ulcers, diabetic ulcers, and for the management of mechanically or surgically debrided wounds. | Unapproved drug claims and those not approved under 510K clearance. | Terminated | ||
| Z-0450-2012 | Microcyn Dermatology Spray with germ killing Preservatives (Rx); 8 fl oz. 99.999% Reduction In-solution in 30 seconds. MRSA - Staphylococcus aureus VFR - Enterococcus faecalis Acinetobacter baumannii Pseudomonas aeruginosa. Microcyn Dermatology Spray has been evaluated by the USP <51> Antimicrobial Effectiveness Test and in Time Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a Category 1 product. Safe to use around eyes, nose and mouth. Oculus Innovative Sciences . Petaluma, CA 94954. Intended for use by health care professionals in management via debridement of wounds | Unapproved drug claims and those not approved under 510K clearance. | Terminated | ||
| Z-0449-2012 | Puracyn OTC; Wound & Skin Care Solution with Preservatives; Sold in 8 fl oz (trigger spray and finder pump) and 16 fl oz pump with insert. Kills 99.99% of Staph, MRSA, Strep and other Infectious Germs in 30 seconds in solution. Does not contain Antibiotics, Steroids or Alcohol. -Cleans infected wounds in one step - Safe to use around eyes, nose, m mouth and open wounds - Accelerated healing of minor wounds by keeping the wound clean -Non-toxic and non-irritating. Manufactured by Oculus Innovative Sciences for Innovaycen, Inc. 3546 N. Riverside Ave. Rialto, CA 92377 Made in USA. Intended for OTC use for the management of skin abrasions, lacerations, minor irritations, cuts, and intact skin. | Unapproved drug claims and those not approved under 510K clearance. | Terminated | ||
| Z-0448-2012 | Microcyn Solution with Preservatives (Rx), 16.9 fl oz (500 mL) and 33.5 fl oz. (990 mL) Ingredients: Electrolyzed Water (99.97%) Sodium Chloride (NaCl) (230 mg/L) and preservatives: Sodium Hypochlorite (Na0Cl) (40 mg/L), Hypochlorous acid (H0CL) (30 mg/L) -Non Foaming -Does not contain antibiotics - Does not facilitate resistance - No known drug/treatment interactions or contraindications -laboratory proven in solution inactivation of bacteria, viruses, fungi and spores. Performance testing: Microcyn Solution with Preservatives has been evaluated by the USP <51> antimicrobial Effectiveness Test and in Time-Kill studies. It has demonstrated effectiveness by reducing the microorganisms listed below and passed the USP antimicrobial Effectiveness test for a category 1 product. Oculus Innovative Sciences' Petaluma, CA 94954. Intended to be used by health care professionals in the management in wounds. | Unapproved drug claims and those not approved under 510K clearance. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain