Cleared Traditional

KALA Therapy Wand (Model: KALA-03)

K250761 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · General & Plastic Surgery

Jul 2025

Decision

120d

Days

Class 2

Risk

About This 510(k) Submission

K250761 is an FDA 510(k) clearance for the KALA Therapy Wand (Model: KALA-03), a Light Based Over The Counter Wrinkle Reduction (Class II — Special Controls, product code OHS), submitted by Shenzhen Kaiyan Medical Equipment Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 11, 2025, 120 days after receiving the submission on March 13, 2025. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K250761 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 13, 2025
Decision Date	July 11, 2025
Days to Decision	120 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

Product Code	OHS — Light Based Over The Counter Wrinkle Reduction
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 878.4810
Definition	Use Of Light Based Treatment To Reduce Wrinkles On The Body In General Or Specific Anatomical Locations Depending On The Information Provided.