IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 B
Summary
Shenzhen Ulike Smart Electronics Co., Ltd. received 510(k) clearance for IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW), a OHT device. Cleared on 2024-01-22.
Details
Source
510(k) Clearance
External ID
K233887
Action Date
2024-01-22
Status
Special
Category
device
Product Code
OHT
Product Description
IPL Hair Removal Device (UI06PN, UI06 PL, UI06 JL, UI06 BR, UI06 DB, UI06 PR, UI06 OG, UI06 RD, UI08 BR, UI08 DB, UI08 BL, UI08 GP, UI08 PN, UI08 RE, UI08 WH, UI08 PW, UI07 BR, UI07 DB, UI07 BL, UI07 GP, UI07 PN, UI07 RE, UI07 WH, UI07 PW, UI20 BR, UI20 DB, UI20 BL, UI20 GP, UI20 PN, UI20 RE, UI20 WH, UI20 PW). 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 389 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 "K233887" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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