FDA Registration
Active
🇬🇧 United Kingdom
Lustre Skin Ltd
Reg #: 3018188770
·
FEI: 3018188770
·
Expires 2026
Products
5
Proprietary Names
9
Establishment Types
4
Classifications
5
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Registration Details
- Registration Name
- Lustre Skin Ltd
- Registration Number
- 3018188770
- FEI Number
- 3018188770
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Alba Innovation Centre, Alba Campus
- City
- Livingston Scotland
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K230124
Owner / Operator
- Firm Name
- Lustre Skin Ltd
- Operator Number
- 10080478
- Address
- Alba Innovation Centre, Alba Campus
- City
- Livingston
- State
- Scotland
- Postal Code
- EH54 7GA
- Country
- GB
- Correspondent
- Blessing Nwabude
US Agent
- Business Name
- Smith Associates
- Contact Name
- Kristi Leigh
- Address
- 1468 Harwell Ave
- City
- Crofton
- State
- MD
- ZIP
- 21114
- Country
- US
- [email protected]
- Phone
- 888 7299674 ext. 203
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tape And Bandage, Adhesive | KGX | Class 1 | General Hospital | No | 2023-05-30 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2023-04-06 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2023-04-06 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2021-02-04 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2022-01-19 |
Proprietary Names
LUSTRESTRIPS Mini Strips
LUSTRESTRIPS
LUSTRESTRIPS Mini Dots
LUSTRE ClearSkin RENEW Pro Facewear Mask
Facegym Lightwear LED Face Mask
LUSTRE ClearSkin SOLO
LUSTRE ClearSkin TRIO
Facegym Acne Light Shot
LUSTRE ClearSkin REVIVE LED Light Therapy Mask
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device
Complaint File Establishment per 21 CFR 820.198