# K251031: Fiber Laser Treatment Systems (HS-232,HS-233)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Apolo Medical Technology Co., Ltd.
- Decided: Jul 2, 2025 after 90 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: 22 generations back to K910422 (1992). 328 ancestors in all.
No later device cites it as a predicate yet.
0 of 329 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221770: Fiber Laser Treatment System, Shanghai Apolo Medical Technology Co., Ltd. (2022) Summary page 5.
- K130193: Fraxel Dual 1550/1927 Laser System, Solta Medical, Inc. (2013) Summary page 5.

## Indications for use
1550nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue. 1927nm: The Fiber Laser Treatment Systems is intended for use in dermatological procedures requiring the coagulation of soft tissue.

Source page: https://510kreport.com/device/K251031
Methodology: https://510kreport.com/methodology