# K240314: Mula (K2-A1)

- Pathway: 510(k) (Traditional)
- Applicant: Guangzhou Ciellulu Photoelectric Technology Co., Ltd.
- Decided: Aug 21, 2024 after 201 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: 21 generations back to K910422 (1992). 345 ancestors in all.
No later device cites it as a predicate yet.
0 of 346 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193500: Stellar M22 for Intense Pulsed Light (IPL) and Laser System, Lumenis, Ltd. (2020) Summary page 5.
- K193072: Lucent : IPL, Luvo Medical Technologies, Inc. (2020) Summary page 5.

## Indications for use
MULA is intended for aesthetic and dermatological skin procedure applications by using multi-filtered Intense Pulsed Light/ Dye Pulsed Light. Intended Use for the 400-1200nm (including 8 filters) Light: 1) Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). 2) Cutaneous lesions, including warts, scars and striae. 3) Benign cutaneous vascular lesions, including port wine stains, hemoangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, facial and leg veins and venous malformations. 4) Removal of unwanted hair and to effect stable long term, or permanent* hair reduction in skin types I-V through selective targeting of melanin in hair follicles. 5) Mild to moderate inflammatory Acne (Acne vulgaris) Note: Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after completion of treatment regime.

Source page: https://510kreport.com/device/K240314
Methodology: https://510kreport.com/methodology