Data / Medical devices / United Kingdom / Lustre Skin Ltd
Lustre Skin Ltd: FDA-registered device maker in Livingston Scotland, United Kingdom, 3 510(k) clearances
Lustre Skin Ltd is registered with the FDA (registration 3018188770) in Livingston Scotland, United Kingdom. It lists 5 device types. The FDA files 3 510(k) clearances under its listings, the newest dated March 15, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018188770
- Address
- Alba Innovation Centre Alba Campus, Livingston Scotland, United Kingdom, EH54 7GA
- Owner or operator
- Lustre Skin Ltd (10080478)
- Roles
- Complaint file establishment, Exporter to the US, Repackager or relabeler, Specification developer
- First device listed
- February 4, 2021
- Registered through
- 2026
- Brand names listed
- Facegym Acne Light Shot, Facegym Lightwear LED Face Mask, LUSTRE ClearSkin RENEW Pro Facewear Mask, LUSTRE ClearSkin REVIVE LED Light Therapy Mask, LUSTRE ClearSkin SOLO, LUSTRE ClearSkin TRIO, LUSTRESTRIPS, LUSTRESTRIPS Mini Dots and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment, Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Complaint file establishment, Exporter to the US, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Complaint file establishment, Exporter to the US, Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Specification developer | accessdata.fda.gov |
| Tape And Bandage, Adhesive | KGX | 1 | Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| March 15, 2023 | K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001) | OHS | Substantially Equivalent | Light Tree Ventures Europe B.V. | accessdata.fda.gov |
| July 14, 2021 | K202390 | Aduro Light Beauty Mask | OHS | Substantially Equivalent | Shenzhen Kaiyan Medical CO , Ltd. | accessdata.fda.gov |
| January 19, 2016 | K143713 | Lustre PRO Light System | GEX | Substantially Equivalent | Ambicare Health, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Over-The-Counter Powered Light Based Laser For Acne
- All makers of Tape And Bandage, Adhesive
- All makers of Powered Laser Surgical Instrument
Updated March 15, 2023. 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.