Class Class II
KALA Therapy Wand (Model: KALA-03) (K250761)
Description
KALA Therapy Wand (Model: KALA-03) by Shenzhen Kaiyan Medical Equipment Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK250761
Clearance Date2025-07-11
Clearance TypeTraditional
Product CodeOHS
Regulation Number878.4810
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250761
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. KALA Therapy Wand (Model: KALA-03) (K250761) cites 3 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59... | Shenzhen Nuon Medical Equipment Co.... | 2024 |
| K241718 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-81... | Shenzhen Aozemei Technology Co., Ltd. | 2024 |
| K161434 | Photon Vibrating massage Facial Aesthetic Device (Model: UI... | Li-Tek Electronics Technologies | 2017 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251076 | Diode Laser Hair Removal Machine (models: T60A, T60B, T60C,... | Shenzhen Lifotronic Technology Co.,... | 2025 |
Trace the full predicate network for K250761
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.