Hakon, Hakon Smart

Medical San Indústria DE Equipamentos Médicos Ltda.

Country / region:Brazil (BR)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

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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

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