Playtex Stella Tampons

FDA 510(k) K180167 · Playtex Manufacturing, Inc.

Substantially Equivalent

510(k) numberK180167

Submission

Device name
Playtex Stella Tampons
Applicant
Playtex Manufacturing, Inc.
Dover, DE, US
Received
January 22, 2018
Decision date
May 30, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HEB – Tampon, Menstrual, Unscented
Device class
Class II (moderate risk)
Regulation
21 CFR 884.5470
Specialty
Obstetrics/Gynecology

An unscented menstrual tampon is a plug made of cellulosic or synthetic material that is inserted into the vagina and used to absorb menstrual fluid or other vaginal discharge.

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K252005Livi DeviceHEB · Traditional Liviwell, Inc.03/20/2026SE
K253719Unscented Menstrual Long Applicator Tampon; Unscented Menstrual Cardboard Applicator…HEB · Special Unibeauty (Hubei) Technology Co., Ltd.12/17/2025SE
K252939Cohitech Organic Cotton Compact Applicator TamponsHEB · Special Cotton High Tech S.L.10/09/2025SE
K252613Unscented menstrual three-piece applicator tamponHEB · Special Unibeauty (Hubei) Technology Co., Ltd.09/19/2025SE
K251033Unscented menstrual long applicator tampon; Unscented menstrual Compact Applicator…HEB · Special Unibeauty (Hubei) Technology Co., Ltd.08/13/2025SE
K242105SABA TamponsHEB · Traditional Essity Higiene Y Salud Mexico. S.A. DE C.V.04/01/2025SE
K241064Unscented TamponHEB · Traditional Shandong Intco Hygiene Products Co., Ltd.01/10/2025SE
K240708Organic Cotton Tampon; Organic Cotton PESCVcord TamponHEB · Traditional Suzhou Borage Medical Technology Co., Ltd.05/10/2024SE
K232060TOSAMA Reusable ApplicatorHEB · Traditional Tosama, D.O.O.04/12/2024SE
K232598Unscented Menstrual TamponHEB · Traditional Unibeauty (Hubei) Technology Co., Ltd.12/15/2023SE

More from Unibeauty (Hubei) Technology Co., Ltd.

510(k)DeviceDecision
K132819Playtex (Scented and Unscented) Sport Fresh Balance TamponsHIL · Special 10/09/2013SE
K111684Playtex Sport (Unscented) ,(Scented) with OdorshieldHIL · Traditional 02/03/2012SE

Questions and answers

When was Playtex Stella Tampons cleared by the FDA?

Playtex Stella Tampons (K180167) received a 510(k) decision of Substantially Equivalent on May 30, 2018, 128 days after the submission was received.

What is the product code of K180167?

The FDA product code is HEB – Tampon, Menstrual, Unscented, a Class II (moderate risk) device regulated under 21 CFR 884.5470.