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510(k) Data Aggregation

K Number

K171879

Device Name

HylaGuard Moisturizing Cream

Manufacturer

Founders Science Group, LLC

Date Cleared

2017-10-16

(115 days)

Product Code

MGQ, FRO

Regulation Number

N/A

Intended Use

HylaGuard Moisturizing Cream is intended for the dressing and management of minor skin irritations and minor burns, including sunburn.

Device Description

HylaGuard Moisturizing Cream is a non-sterile, off-white, low odor, fragrance free, topical device product. HylaGuard Moisturizing Cream forms a semi-permeable, physical barrier that moisturizes and protects skin. HylaGuard Moisturizing Cream is an over-the-counter (OTC) device. The same device has been cleared for prescription use in K150914 under the name of Dash-Topic Plus Cream.

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K Number

K150914

Device Name

Dash-Topic Plus Cream

Manufacturer

Founders Science Group, LLC

Date Cleared

2016-04-21

(381 days)

Product Code

FRO

Regulation Number

N/A

Intended Use

Under the supervision of a healthcare professional, Dash-Topic Plus Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Dash-Topic Plus Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

Device Description

Dash-Topic Plus Cream is a non-sterile, off-white, low odor, fragrance free, topical product. Dash-Topic Plus Cream forms a physical barrier that helps to maintain a moist wound and skin environment. Dash-Topic Plus Cream is a prescription device.

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