# K162398: CO2 Laser Therapy Systems

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Sincoheren Science and Technology Development Co.
- Decided: Jul 6, 2017 after 314 days
- Product code: ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output)
- 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: 7 generations back to K936109 (1994). 19 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161925: CO2 Laser Therapy Machine, Beijing Adss Development Co., Ltd. (2016). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K191518: CO2 Laser System (2019), 1 descendant of its own
- K250998: CO2 Laser Therapy System (Model: LFS-D9U) (2025), 0 descendants of its own

## Indications for use
The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The fractional scanner is only for the treatment of wrinkles and skin resurfacing.

Source page: https://510kreport.com/device/K162398
Methodology: https://510kreport.com/methodology