Data / Medical devices / Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Laser For Disruption Of Adipocyte Cells For Aesthetic Use (PKT): 12 FDA-registered makers in 4 countries
12 establishments in 4 countries are registered with the FDA to make Laser For Disruption Of Adipocyte Cells For Aesthetic Use (product code PKT, Class 2, 21 CFR 878.5400). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on May 13, 2024, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PKT
- Device class
- 2
- Regulation
- 878.5400
- Medical specialty
- General, Plastic Surgery
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| China | 5 |
| Italy | 1 |
| South Korea | 1 |
Makers of Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Cynosure, LLC | Westford, MA, United States | Complaint file establishment, Manufacturer, Specification developer | 6 | January 3, 2019 | 0 | 0 | 0 | api.fda.gov |
| El.en. Electronic Engineering SPA | CALENZANO Firenze, Italy | Manufacturer | 1 | September 26, 2023 | 0 | 0 | 0 | api.fda.gov |
| Hironic Co., Ltd. | Yongin-Si Gyeonggi, South Korea | Manufacturer | 1 | December 1, 2020 | 0 | 0 | 0 | api.fda.gov |
| Hebei JT Medical Co.,Ltd | Baoding Hebei, China | Manufacturer | 1 | May 13, 2024 | 0 | 0 | 0 | api.fda.gov |
| Rhein Laser Technologies Co., Ltd. | wuhan Hubei, China | Complaint file establishment, Manufacturer | 1 | July 17, 2019 | 0 | 0 | 0 | api.fda.gov |
| Rohrer Aesthetics, Inc. | Homewood, AL, United States | Complaint file establishment, Specification developer | 1 | July 17, 2019 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Apolo Medical Technology Co.,ltd. | Shanghai, China | Manufacturer | 1 | September 10, 2020 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Bele Medical Technology Co.,ltd | Shanghai, China | Manufacturer | 1 | June 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Wonderful Opto-Electrics Tech. Co., Ltd | Shanghai, China | Manufacturer | 1 | September 23, 2022 | 0 | 0 | 0 | api.fda.gov |
| Cogmedix | West Boylston, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Venus Concept Inc. | San Jose, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Venus Concept Inc. | Windham, NH, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 13, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.