LightStim for Wrinkles (1984); LightStim for Acne (2038)— 510(k) K261482
Substantially EquivalentLed Intellectual Properties, LLC
FDA 510(k) clearance K261482 for LightStim for Wrinkles (1984); LightStim for Acne (2038), Substantially Equivalent on 2026-07-31. Applicant: Led Intellectual Properties, LLC. Device class: 2.
Summary
Led Intellectual Properties' clearance covers LightStim for Wrinkles (1984) and LightStim for Acne (2038). Both are filed under OHS, light-based over-the-counter wrinkle reduction; the record carries no separate code for the acne product.
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 applicant filed from Irvine, California. Review took 87 calendar days (May 5 to July 31, 2026).
Clearance details
- Applicant
- Led Intellectual Properties, LLC
- 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
- Irvine, CA, US
Recent devices under product code OHS
view allMore clearances from Led Intellectual Properties, LLC
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.