Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
Summary
Hubei Yjt Technology Co.,Ltd received 510(k) clearance for Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500), a OAP device. Cleared on 2026-06-16.
Details
Source
510(k) Clearance
External ID
K253231
Action Date
2026-06-16
Status
Traditional
Category
device
Product Code
OAP
Product Description
Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500). Product code: OAP.
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. Hubei Yjt Technology Co.,Ltd has received 3 total clearances in our database.
Hubei Yjt Technology Co.,Ltd has 3 FDA actions in our database, including 3 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 Hubei Yjt Technology Co.,Ltd have FDA actions?
Hubei Yjt Technology Co.,Ltd has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K253231" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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