Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)
by Shenzhen Nuon Medical Equipment Co., Ltd.
510(k) K251034
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK251034 | Date12 Oct 2025 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- NFO
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.5890
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 28 Sep 2026
The Radiant Renewal Skincare Lid and Wand are transcutaneous electrical stimulators intended for aesthetic purposes. These devices are designed for the treatment of wrinkles for over-the-counter cosmetic use. The product line includes multiple models with different specifications to address various skincare needs.
The devices are manufactured by Shenzhen Nuon Medical Equipment Co., Ltd. and have received FDA 510(k) clearance with product code NFO. They are classified as Class II medical devices under regulation 882.5890. The devices are supplied in various models including HD-59A, HD-59B, HD-70 for the Skincare Lid and HD-44 for the Skincare Wand.
Other devices from Shenzhen Nuon Medical Equipment Co., Ltd.
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Questions
AI-generated answers, 28 Sep 2026
What are the Radiant Renewal Skincare Lid and Wand used for?
The Radiant Renewal Skincare Lid and Wand are transcutaneous electrical stimulators designed for aesthetic purposes, specifically for the treatment of wrinkles in over-the-counter cosmetic use.
What models are available in the Radiant Renewal Skincare product line?
The product line includes multiple models: HD-59A, HD-59B, and HD-70 for the Skincare Lid, and HD-44 for the Skincare Wand, each with different specifications to address various skincare needs.
What is the regulatory status of these devices?
The Radiant Renewal Skincare Lid and Wand have received FDA 510(k) clearance with product code NFO and are classified as Class II medical devices under regulation 882.5890.
Who manufactures the Radiant Renewal Skincare devices?
These devices are manufactured by Shenzhen Nuon Medical Equipment Co., Ltd., a company based in Shenzhen, China, with contact person Alain Dijkstra.