Pro-Tec
Hair-removal electrolysis probes, single-use
4manufacturers in China registered for this device type
15catalogue numbers in this listing
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 | Dectro Intl., Inc., Canada |
|---|---|
| FDA product code | KCW |
| Device type | Epilator, High Frequency, Needle-Type |
| Device class | Class 1 |
| Regulation | 21 CFR 878.5350 |
| Premarket notification | Exempt |
| Record published | 2024-10-09 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Stainless Steel F2 | In distribution | |
| IsoBlend F1 | In distribution | |
| IsoBlend F2 | In distribution | |
| Stainless Steel F4 | In distribution | |
| IsoBlend F3 | In distribution | |
| IsoBlend F4 | In distribution | |
| IsoGard F4 | In distribution | |
| Stainless Steel F1 | In distribution | |
| IsoGard F5 | In distribution | |
| IsoGard F3 | In distribution | |
| IsoGard F1 | In distribution | |
| IsoBlend F5 | In distribution | |
| Stainless Steel F3 | In distribution | |
| Stainless Steel F5 | In distribution | |
| IsoGard F2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Apilus | Dectro Intl., Inc. | 7 |
| Elegance+ | Clareblend, Inc. | 2 |
| G-Tech | Clareblend, Inc. | 1 |
| EZ3 | 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 |
|---|---|
| K943928 | 1995-01-12 |
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.