EZ3
Catalogue number 2018-01U, listed by Clareblend, Inc., United States, under Epilator, High Frequency, Needle-Type. 4 manufacturers in China are registered for this product code.
4manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Zhejiang (2), Guangdong (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Bestway Plastic And Metal Products Ltd. | Dongguan | Guangdong | Manufacturer | 13 |
| Aopu Lighting (Jinyun) Co., Ltd. | Lishui | Zhejiang | Contract manufacturer | 9 |
| Weifang Dragonfly Electronic Technology Co., Ltd. | Weifang | Shandong | Manufacturer | 9 |
| Yongkang Dahua Industry&Trade Co., Ltd. | Yongkang | Zhejiang | Manufacturer | 4 |
Record
| Listed by | Clareblend, Inc., United States |
|---|---|
| FDA product code | KCW |
| Device type | Epilator, High Frequency, Needle-Type |
| Device class | Class 1 |
| Regulation | 21 CFR 878.5350 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-12-14 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied as a kit | Yes |
| Label carries | serial number |
| Storage | Special storage condition: Keep Dry |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 2018-01U | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pro-Tec | Dectro Intl., Inc. | 15 |
| Apilus | Dectro Intl., Inc. | 7 |
| Elegance+ | Clareblend, Inc. | 2 |
| G-Tech | Clareblend, Inc. | 1 |
| Top Epil Classic | Active Optical Systems, Ltd. | 1 |
| Lamprobe | Clareblend, Inc. | 1 |
| Skin Classic | Clareblend, Inc. | 1 |
| Thermoclear Pro | Clareblend, Inc. | 1 |
| ST250 | Silhouet-Tone Corporation | 1 |
| Thermoclear | Clareblend, Inc. | 1 |
| Epic | Clareblend, Inc. | 1 |
| Evolution ST350 | Silhouet-Tone Corporation | 1 |
Showing 12 of 17. All products under Epilator, High Frequency, Needle-Type
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K880553 | 1988-02-29 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.