Manufacturer
Ambicare Health, Ltd.Lustre PRO Light System
Country / Region:United Kingdom (GB)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K143713
- Device name
- Lustre PRO Light System
- Company
- Ambicare Health, Ltd.
- Country / Region
- United Kingdom(GB)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2014-12-29
- Decision date
- 2016-01-19
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Acne treatment
- Primary application
- Acne treatment
- Classification source
- AI classified
Indications for Use
The Lustre PRO light system is indicated for the treatment of mild to moderate acne.
Intended Use
The Lustre PRO light system is indicated for the treatment of mild to moderate acne.
Device Description
The Lustre PRO light system is a small portable non-invasive device, comprising of a rechargeable controller and therapy heads containing light emitting diodes, emitting blue light at a peak wavelength of 415nm, and a Full Width Half Maximum (FWHM) of 15nm. The therapy heads are designed to be attached to the skin at the site of the acne using a disposable polyethylene film impregnated with a medical-grade adhesive. The controller comprises of an LCD graphical user interface, 3 control buttons, a coaxial connector and 3 mini USB connectors. The controller switches the therapy heads on and off and includes a programmable timer, allowing modification of treatment time and indicators for battery level, therapy head status and treatment time remaining. The device contains sensors which monitor the therapy heads and emit audible and visible alarms relating to overheating and disconnection of the therapy heads.
Summary parsed at:2026-06-01 06:05:00 UTC
Predicate devices
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Cited as predicate
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