FAQ (LED Panel); FAQ (Dual LED Panel)— 510(k) K253683
Substantially EquivalentForeo, Inc.
FDA 510(k) clearance K253683 for FAQ (LED Panel); FAQ (Dual LED Panel), Substantially Equivalent on 2026-02-20. Applicant: Foreo, Inc.. Device class: 2.
Summary
Foreo lists two FAQ entries, one marked LED Panel and one marked Dual LED Panel, under product code OHS (Light Based Over The Counter Wrinkle Reduction). The record doesn't describe them beyond those names and that code name.
Class II, 21 CFR 878.4810. General, Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Foreo filed from Las Vegas, Nevada. The decision came 91 calendar days after FDA received it (November 21, 2025 to February 20, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Foreo, Inc.
- 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
- Las Vegas, NV, US
Recent devices under product code OHS
view allMore clearances from Foreo, Inc.
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.