# K211637: Aroma Grand

- Pathway: 510(k) (Traditional)
- Applicant: Daeju Meditech Engineering Co., Ltd.
- Decided: Sep 3, 2021 after 99 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: 1 generation back to K151232 (2015). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151232: VIKINI Diode Laser System, Ilooda Co,., Ltd. (2015) Summary page 4.

## Indications for use
The AROMA GRAND is indicated for hair removal, permanent hair reduction and for the treatment of benign vascular and pigmented lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Source page: https://510kreport.com/device/K211637
Methodology: https://510kreport.com/methodology