The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories
Summary
Lumenis Be, Ltd. received 510(k) clearance for The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories, a GEX device. Cleared on 2022-05-18.
Details
Source
510(k) Clearance
External ID
K220467
Action Date
2022-05-18
Status
Traditional
Category
device
Product Code
GEX
Product Description
The Family of UltraPulse CO2 Surgical and Aesthetic Lasers, Delivery Devices and Accessories. Product code: GEX.
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. Lumenis Be, Ltd. has received 6 total clearances in our database.
Lumenis Be, Ltd. has 6 FDA actions in our database, including 6 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 Lumenis Be, Ltd. have FDA actions?
Lumenis Be, Ltd. has 6 FDA actions in our database, including 0 recalls and 6 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K220467" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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