Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)
Summary
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. received 510(k) clearance for Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9), a OHS device. Cleared on 2026-10-23.
Details
Source
510(k) Clearance
External ID
K262752
Action Date
2026-10-23
Status
Traditional
Category
device
Product Code
OHS
Product Description
Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9). Product code: OHS.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 480 device clearances issued this month. Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. has received 2 total clearances in our database.
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. has 2 FDA actions in our database, including 2 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. have FDA actions?
Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. has 2 FDA actions in our database, including 0 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K262752" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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