Nu Skin RenuSpa iO
Summary
Nse Products, Inc. received 510(k) clearance for Nu Skin RenuSpa iO, a NFO device. Cleared on 2023-11-21.
Details
Source
510(k) Clearance
External ID
K232001
Action Date
2023-11-21
Status
Traditional
Category
device
Product Code
NFO
Product Description
Nu Skin RenuSpa iO. Product code: NFO.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Nse Products, Inc. has 2 FDA actions in our database, including 1 recall and 1 clearance.
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 Nse Products, Inc. have FDA actions?
Nse Products, Inc. has 2 FDA actions in our database, including 1 recall and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K232001" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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