# K173676: A-FIT

- Pathway: 510(k) (Traditional)
- Applicant: Hironic Co., Ltd.
- Decided: Sep 14, 2018 after 288 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: 5 generations back to K002421 (2000). 8 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041242: Candela Smoothbeam Laser System, Candela Corp. (2004) Summary page 5.
- K133739: Trusculpt, Cutera, Inc. (2014) Summary page 6.

## Most influential descendants
- K242207: Noable Laser (2025), 0 descendants of its own

## 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 The RF Hand piece energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

Source page: https://510kreport.com/device/K173676
Methodology: https://510kreport.com/methodology