Apolomed
Diode Laser Body Sculpture System
7manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Shanghai (3), Hubei (2), Hebei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Rhein Laser Technologies Co., Ltd. | Wuhan | Hubei | Complaint-file establishment | 6 |
| Shanghai Apolo Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
| Shanghai Wonderful Opto-Electrics Tech. Co., Ltd. | Shanghai | Shanghai | Manufacturer | 5 |
| Wuhan Lotuxs Technology Co., Ltd. | Wuhan | Hubei | Complaint-file establishment | 5 |
| Hebei JT Medical Co., Ltd. | Baoding | Hebei | Manufacturer | 3 |
| Shanghai Bele Medical Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Beijing Jonte Laser Technology Co., Ltd. | Beijing | Beijing | Exporter | 3 |
Record
| Listed by | Shanghai Apolo Medical Technology Co., Ltd., China |
|---|---|
| FDA product code | PKT |
| Device type | Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5400 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K201731 |
| Record published | 2021-03-26 |
| Record revised | 2026-07-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date, serial number |
| Storage | Handling environment temperature 5 to 30 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| HS-851 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Assy, Mask Flex Circuit, MED, SUB | Cynosure, LLC | 1 |
| Body Laser Applicator Service Pack, Bliss | Venus Concept Ltd. | 1 |
| SculpSure Applicator | Cynosure, LLC | 1 |
| (MP)2 Applicator Service Pack, Bliss | Venus Concept Ltd. | 1 |
| Assy, FNL Laser, Sculpsure, SUB Only Brazil | Cynosure, LLC | 1 |
| Belt Bliss | Venus Concept Ltd. | 1 |
| Body Laser Applicator Bliss | Venus Concept Ltd. | 1 |
| RFB, Assy, Final Laser, Sculpsure, SUB Only | Cynosure, LLC | 1 |
| Bliss System | Venus Concept Ltd. | 1 |
| Assy, Final Laser, Sculpsure, SUB Only | Cynosure, LLC | 1 |
| SculpSure laser assembly | Cynosure, LLC | 1 |
| SculpSure, Laser Assembly, Brazil | Cynosure, LLC | 1 |
Showing 12 of 15. All products under Laser For Disruption Of Adipocyte Cells For Aesthetic Use
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K201731 | 2020-09-10 |
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.