Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
Summary
Canadian Pioneer Medical Technology Corporation received 510(k) clearance for Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares, a GEX device. Cleared on 2022-02-25.
Details
Source
510(k) Clearance
External ID
K211722
Action Date
2022-02-25
Status
Traditional
Category
device
Product Code
GEX
Product Description
Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares. Product code: GEX.
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. Canadian Pioneer Medical Technology Corporation has received 2 total clearances in our database.
Canadian Pioneer Medical Technology Corporation 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 Canadian Pioneer Medical Technology Corporation have FDA actions?
Canadian Pioneer Medical Technology Corporation 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 "K211722" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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