# K182498: Advanced Skin Renewing Device

- Pathway: 510(k) (Traditional)
- Applicant: Jiangsu Unimed Laser Technology Co., Ltd.
- Decided: Nov 30, 2018 after 79 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Advanced Laser Device is indicated for the treatment of periorbital wrinkles, which may result in smoother appearing skin in the treated area.

Source page: https://510kreport.com/device/K182498
Methodology: https://510kreport.com/methodology