PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)— 510(k) K241203

Substantially Equivalent

Dongguan Hunter Electronic Technology Co., Ltd.

FDA 510(k) clearance K241203 for PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT), Substantially Equivalent on 2024-07-25. Applicant: Dongguan Hunter Electronic Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant
Dongguan Hunter Electronic Technology Co., Ltd.
Product code
Code OHS
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Guangdong, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code OHS

product code OHS
Other
1
Total
1

Source: openFDA MAUDE database, through . 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.