# K220794: 10PL

- Pathway: 510(k) (Traditional)
- Applicant: Tentech Co., Ltd.
- Decided: Nov 10, 2022 after 237 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- 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: 23 generations back to K943450 (1995). 570 ancestors in all.
No later device cites it as a predicate yet.
0 of 571 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102857: Ahwon's Ipl System, Ahwon Medi Instrument Co., Ltd. (2011) Summary page 5.
- K181868: SHINY RPL System, Ids, Ltd. (2018) Summary page 5.
- K192539: Deka Luxea, El.En Electronic Engineering Spa (2019) Summary page 5.

## Indications for use
The Photo therapy unit (model: 10PL) is intended for use in surgical and aesthetic applications in dermatology by using filtered Intense Pulsed Light to treat the following conditions with different wavelengths to skin types I-IV. Wavelengths Conditions 415nm - 950nm Melasma 570nm - 950nm Melasma, Rosacea 590nm - 950nm Rosacea, Port wine stains

Source page: https://510kreport.com/device/K220794
Methodology: https://510kreport.com/methodology