Question 1

What types of medical devices does Simple Science, LLC manufacture?

Accepted Answer

Simple Science, LLC specializes in antimicrobial wound irrigation solutions and topical skin cleansers. Their devices are formulated for medical and personal care uses, including wound therapy, eczema treatment, intimate care, facial hygiene, acne management, and post-procedure aftercare like piercings and tattoos. These products are designed to reduce microbial contamination on skin and wounds, with specific formulations for conditions such as viral exposure or rashes.

Question 2

Where is Simple Science, LLC based?

Accepted Answer

Simple Science, LLC is headquartered in the United States. The company’s location ensures compliance with U.S. regulatory standards for medical devices, including those listed in the FDA’s databases.

Question 3

Which regulatory registries or databases list Simple Science, LLC’s devices?

Accepted Answer

Simple Science, LLC’s devices are listed in the FDA’s 510(k) premarket notification database and the Unique Device Identification (UDI) system. These registries ensure transparency and compliance with U.S. medical device regulations, confirming that the products meet applicable requirements.

Question 4

How are Simple Science, LLC’s devices classified under FDA regulations?

Accepted Answer

Simple Science, LLC’s devices fall under Class II classification according to FDA regulations. This classification applies to products that pose moderate risk and require special controls to ensure safety and effectiveness, such as antimicrobial cleansers and wound irrigation solutions. The 510(k) pathway is used to demonstrate that these devices are substantially equivalent to legally marketed predicates.

Device	Model / Reference	Registries	Class	Status
SkinSmart Antimicrobial Men's Intimate Care	7-7390-03	FDA UDI	U	Active
SkinSmart Antimicrobial Skin Cleanser for Eczema Therapy	7-5949-07	FDA UDI	U	Active
SkinSmart Antimicrobial Wound and Skin Cleanser for Wound Therapy	7-7635-00	FDA UDI	U	Active
SkinSmart Antimicrobial Foot Cleanser	7-5588-04	FDA UDI	U	Active
SkinSmart Antimicrobial Skin Cleanser for Eczema Therapy	7-7178-04	FDA UDI	U	Active
SkinSmart Antimicrobial Skin Cleanser (Nipple Spray)	7-7307-01	FDA UDI	U	Active
SkinSmart Antimicrobial Wound and Skin Cleanser for Wound Therapy	7-5956-07	FDA UDI	U	Active
SkinSmart Antimicrobial Facial Cleanser (Virus)	7-5328-02	FDA UDI	U	Active
SkinSmart Antimicrobial Facial Spray (Virus)	7-5284-00	FDA UDI	U	Active
SkinSmart Antimicrobial Piercing and Tattoo Aftercare	7-7376-02	FDA UDI	U	Active
SkinSmart Antimicrobial Face Cleanser (Acne)	7-7208-03	FDA UDI	U	Active
SkinSmart Antimicrobial Rash and Hive Care	7-7338-01	FDA UDI	U	Active
SkinSmart Antimicrobial Skin Cleanser (Baby Eczema)	7-7314-02	FDA UDI	U	Active
SkinSmart Antimicrobial Face Cleanser (Virus)	7-7260-03	FDA UDI	U	Active
SkinSmart Antimicrobial Perineal Cleanser	7-7352-03	FDA UDI	U	Active
CleanSmart Wound Cleanser	K142592	FDA 510(k)	U	Active
Simple Science Antimicrobial Facial and Eyelid Cleanser	K181074	FDA 510(k)	U	Active
Simple Science Antimicrobial Wound & Skin Cleanser 2oz, Simple Science Antimicrobial Wound & Skin Cleanser 8oz, Simple Science Antimicrobial Wound & Skin Cleanser 16oz, Simple Science Antimicrobial Wound & Skin Cleanser 23oz	K160095	FDA 510(k)	U	Active

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