LED Light Therapy Masks (PE748, PE749, PE756)— 510(k) K261496
Substantially EquivalentDuplex International Trading Limited
FDA 510(k) clearance K261496 for LED Light Therapy Masks (PE748, PE749, PE756), Substantially Equivalent on 2026-08-04. Applicant: Duplex International Trading Limited. Device class: 2.
Clearance details
- Applicant
- Duplex International Trading Limited
- Product code
- 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
- Hongkong, CN
Recent devices under product code OHS
view all- K261601 — LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
- K261851 — LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)
- K261482 — LightStim for Wrinkles (1984); LightStim for Acne (2038)
- K260598 — 5 Wavelength LED Facemask (TN2508)
- K261407 — XPREEN LED Light Therapy Masks (XPRE322, XPRE326, XPRE327, XPRE342, XPRE368, XPRE422, XPRE434, XPRE451, XPRE455, XPRE457, XPRE448, XPRE335, XPRE350, XPRE420, XPRE436, XPRE339, XPRE445)
More clearances from Duplex International Trading Limited
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.