# K191349: 980nm Diode Laser Therapy Device

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Apolo Medical Technology Co., Ltd.
- Decided: Aug 16, 2019 after 88 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: 21 generations back to K943450 (1995). 455 ancestors in all.
No later device cites it as a predicate yet.
0 of 456 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151890: Medical Diode Laser Systems, Wuhan Gigaa Optronics Technology Co., Ltd. (2015) Summary page 4.

## Indications for use
HS-890A 980nm Diode Laser Therapy Device is intended for use in surgical application requiring the vaporization , incision, excision, ablation, cutting and hemostasis or coagulation of soft tissue. Such as vascular lesions and dental procedure.

Source page: https://510kreport.com/device/K191349
Methodology: https://510kreport.com/methodology