Eye Recovery Pro (PH-e03)— 510(k) K261602
Substantially EquivalentShenzhen Goodwind Technology Development Co., Ltd.
FDA 510(k) clearance K261602 for Eye Recovery Pro (PH-e03), Substantially Equivalent on 2026-08-10. Applicant: Shenzhen Goodwind Technology Development Co., Ltd.. Device class: 2.
Summary
Shenzhen Goodwind Technology Development filed Eye Recovery Pro, model PH-e03, under product code 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. It came in as a Traditional 510(k).
Goodwind filed from Shenzhen, China. The decision came 88 calendar days after receipt (May 14 to August 10, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Shenzhen Goodwind Technology Development 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
- Shenzhen, CN
Recent devices under product code OHS
view all- K260767 — Facial Beauty Device (Facial Mask LED Beauty Device A-901 +2 more
- K261601 — LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)
- K261496 — LED Light Therapy Masks (PE748, PE749, PE756)
- K261851 — LED Light Therapy Mask (5 models)
- K261482 — LightStim for Wrinkles (1984); LightStim for Acne (2038)
More clearances from Shenzhen Goodwind Technology Development Co., Ltd.
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.