Data / Medical devices / United States / Sonoma Pharmaceuticals, Inc.

Sonoma Pharmaceuticals, Inc.: FDA-registered device maker in Boulder, CO, United States, 14 510(k) clearances

Name: Sonoma Pharmaceuticals, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sonoma Pharmaceuticals, Inc. is registered with the FDA (registration 3004554409) in Boulder, CO, United States. It lists 3 device types. The FDA files 14 510(k) clearances under its listings, the newest dated September 13, 2024. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3004554409
Address: 5445 Conestoga Ct Ste 150, Boulder, CO, United States, 80301
Owner or operator: Sonoma Pharmaceuticals Inc. (9063175)
Roles: Complaint file establishment, Manufacturer, Specification developer
First device listed: November 2, 2009
Registered through: 2026
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	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
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
November 21, 2016	75770	Class II	Terminated	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	Firm became aware that professional samples of Ceramax are not meeting stability standards set for the product.	accessdata.fda.gov
February 12, 2013	64316	Class II	Terminated	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	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.	accessdata.fda.gov
November 9, 2011	60387	Not yet classified	Terminated	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),	Unapproved drug claims and those not approved under 510K clearance.	accessdata.fda.gov

Compare with other makers

Updated September 13, 2024. 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.