Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Super Hair Removal (SHR) mode is intended for the temporary reduction of hair. The Hair Removal (HR) and Super Hair Removal (SHR) modes are intended for the permanent reduction of hair regrowth, defined as a stable and long-term reduction in the number of hairs that regrow, measured at 6, 9, and 12 months after completing a treatment regimen. It is suitable for use on all skin types (Fitzpatrick I-VI), including tanned skin, when using the HR and SHR mode.
The Super Hair Removal (SHR) mode is intended for the temporary reduction of hair. The Hair Removal (HR) and Super Hair Removal (SHR) modes are intended for the permanent reduction of hair regrowth, defined as a stable and long-term reduction in the number of hairs that regrow, measured at 6, 9, and 12 months after completing a treatment regimen. It is suitable for use on all skin types (Fitzpatrick 1-VI), including tanned skin, when using the HR and SHR mode.
VEGA is a high-power laser therapy device with electromagnetic emission in the infrared spectrum, designed for long-lasting hair removal on all skin types. Laser energy can be transferred to the treatment area via an 810nm or triple wave (755, 810, 1064nm) handpiece.
Summary parsed at:2026-06-01 05:21:16 UTC
