XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)— 510(k) K261407
Substantially EquivalentDongguan Miqiang Technology Co., Ltd.
FDA 510(k) clearance K261407 for XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445), Substantially Equivalent on 2026-07-15. Applicant: Dongguan Miqiang Technology Co., Ltd.. Device class: 2.
Summary
Dongguan Miqiang Technology's XPREEN LED Light Therapy Masks are listed in 17 models, from XPRE322 to XPRE457, filed under OHS, light-based over-the-counter wrinkle reduction. The record doesn't say how the models differ.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Dongguan Miqiang filed from Dongguan, China. Review took 77 calendar days (April 29 to July 15, 2026).
Clearance details
- Applicant
- Dongguan Miqiang Technology Co., Ltd.
- Product code
- Product code OHS
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Dongguan, CN
Recent devices under product code OHS
view allAdverse events under product code OHS
product code OHS- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.