Data / Medical devices / United States / Evoskin LLC
Evoskin LLC: FDA-registered device maker in Burlington, MA, United States, 1 510(k) clearance
Evoskin LLC is registered with the FDA (registration 3021334828) in Burlington, MA, United States. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated August 15, 2022. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3021334828
- Address
- 6 Lincoln Knoll Ln Ste 100A, Burlington, MA, United States, 01803
- Owner or operator
- Evoskin LLC (10084093)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- November 17, 2022
- Registered through
- 2027
- Brand names listed
- ENDORET, FUSE X, XLASE PLUS
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Manual | GED | 1 | Specification developer | accessdata.fda.gov |
| Platelet And Plasma Separator For Bone Graft Handling | ORG | 2 | Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 15, 2022 | K212790 | XLase Plus | GEX | Substantially Equivalent | Biotec Italia, Srl | accessdata.fda.gov |
Compare with other makers
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Platelet And Plasma Separator For Bone Graft Handling
- All makers of Brush, Dermabrasion, Manual
Updated August 15, 2022. 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.