Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S
Summary
Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. received 510(k) clearance for Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S), a OHT device. Cleared on 2024-06-24.
Details
Source
510(k) Clearance
External ID
K241120
Action Date
2024-06-24
Status
Traditional
Category
device
Product Code
OHT
Product Description
Intense pulsed light therapy apparatus (FDA01, FDA02, FDA03, FDA04S, FDA05S, FDA06, FDA06S, FDA07, FDA07S, FDA08, FDA09S, FDA10S). Product code: OHT.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 534 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 Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. have FDA actions?
Qiaocheng LI (Dongguan) Medical Instruments Co., Ltd. has 0 FDA actions in our database, including 0 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K241120" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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