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FDA 510(k)

HYLATOPICPLUS CREAM

K-Number: K110727 · 2011-04-01

ApplicantPrecision Dermatology Incorporated
Decision Date2011-04-01
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

HYLATOPICPLUS CREAM is the device name listed in this FDA 510(k) record. The listed applicant is Precision Dermatology Incorporated. It received FDA 510(k) clearance on 2011-04-01 under 510(k) number K110727. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYLATOPICPLUS CREAM?

HYLATOPICPLUS CREAM is a medical device that received FDA 510(k) clearance on 2011-04-01. The listed applicant is Precision Dermatology Incorporated. The 510(k) number is K110727.

When did HYLATOPICPLUS CREAM receive FDA 510(k) clearance?

HYLATOPICPLUS CREAM received FDA 510(k) clearance on 2011-04-01, under 510(k) number K110727.

Who is the listed applicant for HYLATOPICPLUS CREAM?

The FDA 510(k) record lists Precision Dermatology Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYLATOPICPLUS CREAM?

The FDA product code for HYLATOPICPLUS CREAM is FRO. This falls under the Anesthesiology category.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Precision Dermatology Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K121559HYLATOPICPLUS LOTIONK111168PRECISION SKIN EMULSION

Related Devices (Code: FRO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254168Actolind® (06.3637. Actolind® Gel Plus)ACTO GmbHK254041SkinSmart Antimicrobial HydroGelMagic Science Supply, LLCK261646Redermax® Antibacterial Wound MatrixBeijing Kreate Medical Co., Ltd.K253665Vashe Plus Antimicrobial SolutionUrgo Medical North America, LLCK251929SilverCeuticals® Antimicrobial Wound GelSilverceuticals, Inc.K261023Microdacyn Wound Irrigation SolutionSonoma Pharmaceuticals, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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