Hakon, Hakon Smart
Medical San Indústria DE Equipamentos Médicos Ltda.
Country / Region:Brazil (BR)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
- K231901
- Device name
- Hakon, Hakon Smart
- Country / Region
- Brazil(BR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-06-28
- Decision date
- 2023-09-28
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The Dermatological Diode Laser (Model: Hakon and Hakon Smart) are intended for the removal, permanent reduction of hair on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent hair reduction is defined as the stable, longterm reduction in the number of hairs growing back when measured at 6, 9, and 12 months after completion of a treatment regimen.
Intended Use
The Dermatological Diode Laser (Model: Hakon and Hakon Smart) are intended for the removal, permanent reduction of hair on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent hair reduction is defined as the stable, longterm reduction in the number of hairs growing back when measured at 6, 9, and 12 months after completion of a treatment regimen.
Device Description
The Hakon and Hakon Smart device is a micro-controlled equipment used in diode laser therapies at wavelengths of 808nm intended to remove unwanted hair. The technique is based on the principle of selective thermal destruction, specifically targeting the germinal cells within the hair follicle. By utilizing laser light, the melanin present in the hair absorbs the energy, leading to the destruction of the hair bulbs in the anagen phase. The anagen phase represents the active growth stage of the hair follicle, characterized by highly pigmented matrix cells and a connection to the dermal papilla. It is during this phase that the treatment achieves its highest success rates. Melanin, being the primary chromophore in hair follicles, enables the utilization of light wavelengths ranging from 600 to 1100nm for safe and effective selective photo thermolysis. These wavelengths ensure optimal targeting of the hair follicles while maintaining efficacy and safety throughout the treatment process.
Summary parsed at:2026-06-01 05:33:10 UTC
Predicate devices
1Dermatological Diode Laser Systems
K231901 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K231901 as a predicate
