SculpSure Applicator, Refurbished
Catalogue number R100-7026-100, listed by Cynosure, LLC, United States, under Laser For Disruption Of Adipocyte Cells For Aesthetic Use. 7 manufacturers in China are registered for this product code.
7manufacturers in China registered for this device type
1catalogue number
6510(k) clearances naming this product code
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 | Cynosure, LLC, United States |
|---|---|
| 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 | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2017-07-24 |
| Record revised | 2026-07-21 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R100-7026-100 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K182741 | 2019-01-03 |
| K171992 | 2017-09-26 |
| K171111 | 2017-06-13 |
| K160470 | 2016-07-21 |
| K150724 | 2015-07-01 |
| K150230 | 2015-05-15 |
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.