# K251781: Kala Mini 2.0 (Kala-04)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Decided: Sep 4, 2025 after 85 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- 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 K943450 (1995). 337 ancestors in all.
No later device cites it as a predicate yet.
0 of 338 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242151: Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B), Shenzhen Nuon Medical Equipment Co., Ltd. (2025) Summary page 6.
- K232977: Biophotas Celluma CONTOUR, Biophotas, Inc. (2023) Summary page 6.
- K101716: HVR Pain Relief Device, H.V.R., Inc. (2011) Summary page 6.

## Indications for use
KALA MINI 2.0 (Model: KALA-04) (Mode 1) is intended to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation. KALA MINI 2.0 (Model: KALA-04) (Mode 2) is an over-the counter device intended for the treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K251781
Methodology: https://510kreport.com/methodology