# K242207: Noable Laser

- Pathway: 510(k) (Traditional)
- Applicant: Daeju Meditech Engineering Co., Ltd.
- Decided: Mar 7, 2025 after 221 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: 6 generations back to K002421 (2000). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173676: A-FIT, Hironic Co., Ltd. (2018) Summary page 5.

## Indications for use
For use in dermatology: incision, excision, ablation, and vaporization with hemostasis of soft tissue, Treatment of back acne Treatment of atrophic acne scars Treatment of facial wrinkles Treatment of mild to moderate acne vulgaris Treatment of Sebaceous Hyperplasia

Source page: https://510kreport.com/device/K242207
Methodology: https://510kreport.com/methodology