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.
Summary
Duplex International Trading's LED Light Therapy Masks list three models: PE748, PE749, and PE756. The product code is OHS, light based over-the-counter wrinkle reduction.
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).
The record lists the applicant location as Hongkong, with country code CN. The decision came 90 calendar days after receipt (May 6 to August 4, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Duplex International Trading Limited
- 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
- Hongkong, CN
Recent devices under product code OHS
view allMore 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.