Deka Physiq 360
The PHYSIQ 360 is a diode laser device. The device is provided with 4 applicators that deliver the laser energy to the patient (to subcutaneous tissue layers).
7manufacturers in China registered for this device type
1catalogue number
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 | Deka M.e.l.a. SRL |
|---|---|
| FDA product code | PKT |
| Device type | Laser For Disruption Of Adipocyte Cells For Aesthetic Use |
| Device class | Class 2 |
| Regulation | 21 CFR 878.5400 |
| 510(k) | K231971 |
| Record published | 2023-10-11 |
| Record revised | 2025-05-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature 5 to 50 °C; Storage environment humidity 10 to 90 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal; Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 70 to 1060 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M134A1 | 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 |
| Apolomed | Shanghai Apolo Medical Technology Co., 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 |
Showing 12 of 15. All products under Laser For Disruption Of Adipocyte Cells For Aesthetic Use
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.