Manufacturer
Ibramed Equipamentos MédicosVEGA
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
- K242859
- Device name
- VEGA
- Company
- Ibramed Equipamentos Médicos
- Country / Region
- Brazil(BR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-09-20
- Decision date
- 2025-09-19
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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
Predicate devices
2The Alma Soprano Titanium
SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC
K242859 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K242859 as a predicate