Cleared Traditional

EnergyLounger (TY-01)

K241947 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · General & Plastic Surgery

Mar 2025

Decision

243d

Days

Class 2

Risk

About This 510(k) Submission

K241947 is an FDA 510(k) clearance for the EnergyLounger (TY-01), 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 March 3, 2025, 243 days after receiving the submission on July 3, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K241947 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2024
Decision Date	March 03, 2025
Days to Decision	243 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.