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Opal by Femtex and Private Label Unscented Compact Applicator Tampon

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151470

by First Quality Hygienic, Inc.

Identifiers

510(k) Number
K151470 FDA 510(k)
FDA Product Code
HEB FDA 510(k)
Models / Variants
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Light Absorbency FDA 510(k)
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Regular & Super FDA 510(k)
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Plus FDA 510(k)
Opal by Femtex and Private Label Unscented Compact Applicator Tampon, Super Absorbency FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 884.5470 FDA 510(k)
Regulation Number
884.5470 FDA 510(k)
Advisory Committee
Obstetrics/Gynecology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Opal by Femtex and Private Label Unscented Compact Applicator Tampon is a menstrual tampon designed for women's personal hygiene, specifically for intra-vaginal absorption of menstrual or other vaginal discharge. It features a plastic applicator to facilitate correct placement into the vagina.

This device is available in multiple absorbencies: Light, Regular & Super, Super Plus, and Super Absorbency. It is a single-use product and has received FDA 510(k) clearance as a Class II medical device. The device is manufactured by First Quality Hygienic, Inc.

Frequently asked questions

What is the Opal by Femtex tampon used for?

The Opal by Femtex tampon is designed for women's personal hygiene, specifically for intra-vaginal absorption of menstrual or other vaginal discharge. It features a plastic applicator to facilitate correct placement into the vagina.

What absorbency options are available for the Opal tampon?

The Opal tampon is available in multiple absorbencies: Light, Regular & Super, Super Plus, and Super Absorbency. This range allows users to select the appropriate absorbency level based on their menstrual flow needs.

Is the Opal tampon single-use or reusable?

The Opal tampon is a single-use product. It should be discarded after each use and not reused to maintain hygiene and prevent potential health risks associated with reuse.

What is the regulatory status of the Opal tampon?

The Opal tampon has received FDA 510(k) clearance as a Class II medical device. This means it has been determined to be substantially equivalent to other legally marketed tampons in terms of safety and effectiveness.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Opal by Femtex and Private Label Unscented Compact Applicator Tampon ..., Opal by Femtex and Private Label Unscented Compact Applicator Tampon ..., PDF Microsoft Word - 510k Summary_cjg revision_062115

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
First Quality Hygienic, Inc.

Sources (1)

  • FDA 510(k) K151470 24 fields · synced Oct 1, 2026