EndyMed Pure 2.0 System 220v Pure Logo
Catalogue number Pure 2.0 system 220V PURE logo, listed by Endymed Medical Ltd, Israel, under Skin Resurfacing Rf Applicator. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code
Who Else Makes It
Concentrated in Guangdong (1), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Syntech Laser Co., Ltd. | Beijing | Beijing | Contract manufacturer | 5 |
| Guangdong Fuqiang Beauty Equipment Co., Limited | Qingyuan | Guangdong | Manufacturer | 13 |
Record
| Listed by | Endymed Medical Ltd, Israel |
|---|---|
| FDA product code | OUH |
| Device type | Skin Resurfacing Rf Applicator |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4400 |
| Establishment | Manufacturer |
| 510(k) | K120513 |
| Record published | 2019-03-03 |
| Record revised | 2025-06-30 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2023-06-25 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Pure 2.0 system 220V PURE logo | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| INTRAgen Tip | Jeisys Medical Inc. | 2 |
| INTRAgen | Jeisys Medical Inc. | 1 |
| Max-M25C | Classys Inc | 1 |
| Virtue RF Microneedle Cartridge | ShenB Co Ltd | 1 |
| Quadessy Set Package | Classys Inc | 1 |
| Virtue RF | ShenB Co Ltd | 1 |
| Max-M25 | Classys Inc | 1 |
| EndyMed Intensif 10 pack tips package | Endymed Medical Ltd | 1 |
| Max-25C | Classys Inc | 1 |
| Max-25 | Classys Inc | 1 |
| Vivace Electrosurgical System | ShenB Co Ltd | 1 |
| Fraxis Duo Needle H/P | Ilooda Co,., Ltd. | 1 |
Showing 12 of 24. All products under Skin Resurfacing Rf Applicator
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K130501 | 2014-03-13 |
| K120513 | 2012-05-08 |
| K101510 | 2011-02-17 |
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.