Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004554409

FEI Number

3004554409

Entity Name

Sonoma Pharmaceuticals, Inc.

City/State/Country

Boulder, CO, US

Establishment Address

5445 Conestoga Ct Ste 150, Boulder, CO 80301, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Sonoma Pharmaceuticals Inc. (Owner Number: 9063175)

Owner / Operator Contact Address

5445 Conestoga Court, Suite 150, Boulder, CO 80301, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K233399

PMA Number

N/A

All Registered Proprietary Names

Sebuderm Endocyn Microcyn Scar Management Hydrogel Aquanil AD Recovery Gel Advanced Scar & Wound Hydrogel A+D Cleansing & Skin Support Spray A+D Antimicrobial Hydrogel Spray A+D Advanced Dermatitis Care Spray Hydrogel Aquanil AD Rescue Serum PhaseOne Antimicrobial Solution Lasercyn Post Procedure Gel Solarcaine Advanced Burn Relief Hydrogel Bactine Antimicrobial Wound Care Hydrogel VHE Bikini Soothing Gel Aquanil AD Repair Mist Loyon PureWash Wound Cleanser MYZE The Spray

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2016-10-21
KJJ	Cleanser, Root Canal	Unknown	Class U	N/A	2015-07-28
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2013-12-04
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-01-24
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-04-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-12-18
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2018-04-17
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2017-08-16
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2025-01-24

Official Correspondent

Arturo Angel

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Sonoma Pharmaceuticals Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007244484	Oculus Technologies of Mexico, S.A de C.V.	Zapopan Jalisco, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K150256	Argentum Medical	SILVERLON BURN CONTACT DRESSINGS	2015-04-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
Z-0011-2020	Inter-Med Llc	U	Vista Dental Products CanalClean Endodontic Irrigation Kit, (1) 12mL - Chlor-XTRA, 6mL - SmearOFF + 92) + (2) 30ga Irrigation Tips + (1) Micro Aspirator with Tip, REF 504700
Z-0012-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Z-0013-2020	Inter-Med Llc	U	Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315

Similar Registrations

Registration Number	Establishment Name	Location
3010067148	SERIOUSLY CLEAN LTD	Nixa, MO, US
3043618351	NEORES D.O.O.	Mursko Sredisce Medimurska Zupanija, HR
3007128716	Medline Industries, LP	Norristown, PA, US
3012456427	UFP TECHNOLOGIES, INC.	Newburyport, MA, US
3019843904	OMEZA, LLC	Sarasota, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004554409. Last updated year: 2026. Please use registration number 3004554409 when referencing this establishment in official correspondence.