# K242859: VEGA

- Pathway: 510(k) (Traditional)
- Applicant: Ibramed Equipamentos Médicos
- Decided: Sep 19, 2025 after 364 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 26 generations back to K943450 (1995). 567 ancestors in all.
No later device cites it as a predicate yet.
0 of 568 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222862: SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC, Lotuxs Medtech (Suzhou) Co., Ltd. (2023) Summary page 5.
- K222064: The Alma Soprano Titanium, Alma Lasers, Inc. (2022) Summary page 5.

## Indications for use
Vega Triple Wave Applicator (755nm/ 810nm/ 1064nm) Indications for use of the Triple Wave Applicator, Includes: The Super Hair Removal (SHR) mode is intended for the temporary reduction of hair. Vega 810nm Applicator: Indications for use of the 810nm Applicator, Includes: 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.

Source page: https://510kreport.com/device/K242859
Methodology: https://510kreport.com/methodology