FDA device listing
Ice Cooling IPL Hair Removal Device;,Model(S): UI06S PR, UI06S PN, UI06S WH
FDA device listing 1437216274 · Shenzhen Ulike Smart Electronics Co.,Ltd
Key facts
| Proprietary names | Ice Cooling IPL Hair Removal Device;,Model(S): UI06S PR, UI06S PN, UI06S WH |
|---|---|
| Owner/operator | Shenzhen Ulike Smart Electronics Co.,Ltd |
| Owner/operator number | 10085336 |
| Premarket submissions | K250194 |
| Product codes | OHT |
| Device names | OHT - Light Based Over-The-Counter Hair Removal |
| Device class | Class II |
| Classification regulations (21 CFR) | 878.4810 |
| Review panels | General & Plastic Surgery |
| Registered establishments | SHENZHEN ULIKE SMART ELECTRONICS CO.,LTD |
| Establishment registrations | 3023339103 |
| FEI numbers | 3023339103 |
| Establishment operations | Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database