meddevicedb.com FDA Device Reference

Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)

K242700 Class II Traditional
Decision Date
2024-12-19
Sponsor / Applicant
Shenzhen Nuon Medical Equipment Co., Ltd.

Technical Specification

510(k) Submission ID K242700
Product Code OHS
Medical Specialty / Panel General, Plastic Surgery
Regulation Citation 21 CFR 878.4810
Decision Date 2024-12-19
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) received FDA 510(k) clearance under submission number K242700, sponsored by Shenzhen Nuon Medical Equipment Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 2024-12-19.

Classification & Regulation

This clearance is catalogued under FDA product code OHS and 21 CFR 878.4810, within the General, Plastic Surgery review panel as a Class II device.