IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG
Summary
Shenzhen Ulike Smart Electronics Co., Ltd. received 510(k) clearance for IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG), a OHT device. Cleared on 2024-01-05.
Details
Source
510(k) Clearance
External ID
K233679
Action Date
2024-01-05
Status
Traditional
Category
device
Product Code
OHT
Product Description
IPL Hair Removal Device (UI04 MK,UI04 BN,UI04 BU,UI04 CB,UI04 GY,UI04 LG,UI04 DG,UI04 PL,UI04 PN,UI04 SD,UI04 SG,UI04 MG). 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 "K233679" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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