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FDA 510(k)

HYLATOPICPLUS LOTION

K-Number: K121559 · 2012-11-30

ApplicantPrecision Dermatology Incorporated
Decision Date2012-11-30
Product CodeFRO
DecisionSubstantially Equivalent

Device Summary

HYLATOPICPLUS LOTION 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 2012-11-30 under 510(k) number K121559. 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 LOTION?

HYLATOPICPLUS LOTION is a medical device that received FDA 510(k) clearance on 2012-11-30. The listed applicant is Precision Dermatology Incorporated. The 510(k) number is K121559.

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

HYLATOPICPLUS LOTION received FDA 510(k) clearance on 2012-11-30, under 510(k) number K121559.

Who is the listed applicant for HYLATOPICPLUS LOTION?

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 LOTION?

The FDA product code for HYLATOPICPLUS LOTION 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.

K111168PRECISION SKIN EMULSIONK110727HYLATOPICPLUS CREAM

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

View on FDA Database →

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

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