# K220214: Painless IPL System - KDT750

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Omni Laser Skinology Co., Ltd.
- Decided: Feb 18, 2023 after 388 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: 15 generations back to K943450 (1995). 239 ancestors in all.
No later device cites it as a predicate yet.
0 of 240 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 4.

## Indications for use
The IPL System - KDT750 is intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Indications for use for IPL System with 515-980nm IPL Handpiece (SR Handpiece). • Benign pigmented epidermal and cutaneous lesions including warts, melasma, epithelides (freckles) and lentigines. • Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, rosacea, erythema of rosacea and poikiloderma of Civatte. • For use on skin types(I-V) Indications for use for IPL System with 640-950nm IPL Handpiece (HR Handpiece). • The removal of unwanted hair to effect stable long-term or permanent hair reduction. • For use on Fitzpatrick skin types (I-V) * Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Source page: https://510kreport.com/device/K220214
Methodology: https://510kreport.com/methodology