Wet Light Personal Moisturizer

Q: What is the product code of K013086?

The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.

FDA 510(k) K013086 · Trigg Laboratories, Inc.

Substantially Equivalent

510(k) numberK013086

Submission

Device name: Wet Light Personal Moisturizer
Applicant: Trigg Laboratories, Inc.
Woodland Hills, CA, US
Received: September 14, 2001
Decision date: December 13, 2001
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code: HIS – Condom
Device class: Class II (moderate risk)
Regulation: 21 CFR 884.5300
Specialty: Obstetrics/Gynecology

Other 510(k)s with product code HIS

510(k)	Device	Applicant	Decision
K252622	Male Latex Condom HAHIS · Abbreviated	Okamoto USA, Inc.	05/04/2026SE
K252521	LifeStyles® HydraFeel Natural Rubber Latex CondomHIS · Abbreviated	Suretex Limited	11/18/2025SE
K250034	Natural rubber latex male condomHIS · Traditional	Shaoguan Regenex Pharmaceuticals Co., Ltd.	07/11/2025SE
K243421	Lelo Hex Lubricated Natural Rubber Latex CondomHIS · Traditional	Lelo, Inc.	03/07/2025SE
K243640	Trojan Ultra Ribbed Ecstasy latex condom with lubricant (Trojan Ultra Ribbed Ecstasy)HIS · Traditional	Church & Dwight Co., Inc.	02/21/2025SE
K243584	0.04 ZERO ZERO FOUR Male Latex CondomHIS · Abbreviated	Okamoto USA, Inc.	02/18/2025SE
K232279	LifeStyles NRL Textured CondomHIS · Abbreviated	Suretex Limited	10/05/2023SE
K230049	SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE Dots…HIS · Traditional	Ttk Healthcare Limited	09/07/2023SE
K222611	Male Latex CondomsHIS · Traditional	Suzhou Colour-Way New Material Co., Ltd.	11/28/2022SE
K220489	Durex Patronus CloseFit, Durex Patronus RegularHIS · Traditional	Rb Health (Us), LLC	11/07/2022SE

More from Rb Health (Us), LLC

510(k)	Device	Decision
K221829	Wet Flavored Personal LubricantsNUC · Traditional	09/23/2022SE
K220534	Wet Essential95 Personal LubricantNUC · Traditional	07/07/2022SE
K130012	Wet Platinum Personal LubricantNUC · Traditional	08/22/2013SE

Questions and answers

When was Wet Light Personal Moisturizer cleared by the FDA?

Wet Light Personal Moisturizer (K013086) received a 510(k) decision of Substantially Equivalent on December 13, 2001, 90 days after the submission was received.

What is the product code of K013086?

The FDA product code is HIS – Condom, a Class II (moderate risk) device regulated under 21 CFR 884.5300.