Leos Laser and Endoscopy System
Summary
Beaver-Visitec International, Inc. received 510(k) clearance for Leos Laser and Endoscopy System, a HQF device. Cleared on 2025-04-03.
Details
Source
510(k) Clearance
External ID
K240615
Action Date
2025-04-03
Status
Traditional
Category
device
Product Code
HQF
Product Description
Leos Laser and Endoscopy System. Product code: HQF.
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.
Beaver-Visitec International, Inc. has 182 FDA actions in our database, including 181 recalls 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 Beaver-Visitec International, Inc. have FDA actions?
Beaver-Visitec International, Inc. has 182 FDA actions in our database, including 181 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K240615" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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