Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI
Summary
Shenzhen Ulike Smart Electronics Co., Ltd. received 510(k) clearance for Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN), a OHT device. Cleared on 2025-05-23.
Details
Source
510(k) Clearance
External ID
K250938
Action Date
2025-05-23
Status
Traditional
Category
device
Product Code
OHT
Product Description
Ice Cooling IPL Hair Removal Device (MI01 LP, MI01 CB, MI01 GR, MI01 PP, MI01 RM, MI01 WG, MI01 WH, MI01 BK;UI04S PP, UI04S BU, UI04S WH, UI04S PN). 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 403 device clearances issued this month. Shenzhen Ulike Smart Electronics Co., Ltd. has received 21 total clearances in our database.
Shenzhen Ulike Smart Electronics Co., Ltd. has 21 FDA actions in our database, including 21 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 Ulike Smart Electronics Co., Ltd. have FDA actions?
Shenzhen Ulike Smart Electronics Co., Ltd. has 21 FDA actions in our database, including 0 recalls and 21 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K250938" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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