HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM— 510(k) K122595

Substantially Equivalent

Dermal Life, LLC

FDA 510(k) clearance K122595 for HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM, Substantially Equivalent on 2013-05-01. Applicant: Dermal Life, LLC.

Clearance details

Applicant: Dermal Life, LLC
Product code: Code FRO
Advisory panel: Unknown
Date received: 2012-08-24
Decision date: 2013-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfax, VA, US

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Adverse events under product code FRO

product code FRO

Death: 30
Injury: 653
Malfunction: 479
Other: 11
Total: 1,173

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.