Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)— 510(k) K262752

Substantially Equivalent

Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.

FDA 510(k) clearance K262752 for Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9), Substantially Equivalent on 2026-10-23. Applicant: Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.. Device class: 2.

Clearance details

Applicant
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.
Product code
Product 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
Shenzhen, 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.