FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm
Summary
Gme German Medical Engineering GmbH received 510(k) clearance for FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm, a GEX device. Cleared on 2023-03-10.
Details
Source
510(k) Clearance
External ID
K221623
Action Date
2023-03-10
Status
Traditional
Category
device
Product Code
GEX
Product Description
FlexSys, FlexSys UVB EPL 308 nm, FlexSys UVB EPL lite 308 nm, FlexSys IR 1550 nm. 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.
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 Gme German Medical Engineering GmbH have FDA actions?
This is the only FDA action we have on record for Gme German Medical Engineering GmbH in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K221623" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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