# K242206: Activo

- Pathway: 510(k) (Traditional)
- Applicant: Daeju Meditech Engineering Co., Ltd.
- Decided: Sep 27, 2024 after 60 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: 19 generations back to K943450 (1995). 271 ancestors in all.
No later device cites it as a predicate yet.
0 of 272 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152856: Helios III, Laseroptek Co., Ltd. (2016) Summary page 5.

## Indications for use
Incision, excision, ablation, vaporization of soft tissue for general dermatology (1064 nm) Tattoo Removal: Dark ink (blue and black) (1064 nm) Tattoo Removal: light ink (red, sky blue, green) (532 nm) telangiectasias (532 nm) spider nevi (532 nm) solar lentiginos, senile lentiginos, becker's nevi, freckles (532 nm) nevus of ota (1064 nm)

Source page: https://510kreport.com/device/K242206
Methodology: https://510kreport.com/methodology