Diode Laser System GP900A8, Diode Laser System GP900Q8
Summary
Shenzhen Gsd Tech Co., Ltd. received 510(k) clearance for Diode Laser System GP900A8, Diode Laser System GP900Q8, a GEX device. Cleared on 2021-12-22.
Details
Source
510(k) Clearance
External ID
K213225
Action Date
2021-12-22
Status
Traditional
Category
device
Product Code
GEX
Product Description
Diode Laser System GP900A8, Diode Laser System GP900Q8. 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. Shenzhen Gsd Tech Co., Ltd. has received 2 total clearances in our database.
Shenzhen Gsd Tech Co., Ltd. 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 Shenzhen Gsd Tech Co., Ltd. have FDA actions?
Shenzhen Gsd Tech Co., Ltd. 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 "K213225" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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