LightStim Anti-Wrinkle OTC Model AAL
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101190 FDA 510(k)
- FDA Product Code
- OHS FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LightStim Anti-Wrinkle OTC Model AAL is a Light-Based Over-The-Counter Wrinkle Reduction device, classified under FDA regulation 878.4810. This device employs light stimulation technology to target and reduce the appearance of wrinkles on the skin, functioning as a non-invasive cosmetic treatment for at-home use.
Intended for single-use or reusable application in a home or clinical setting, the device is designed for over-the-counter availability without requiring professional administration. It operates under FDA clearance (510(k) K101190) as substantially equivalent to a predicate device, adhering to regulatory standards for light-based cosmetic treatments. No specific sterility or MRI safety information is provided in the data.
Frequently asked questions
Is the LightStim Anti-Wrinkle OTC Model AAL designed for professional use in a clinical setting, or is it intended for at-home use by consumers?
The LightStim Anti-Wrinkle OTC Model AAL is explicitly designed for over-the-counter availability and is intended for at-home use by consumers. While it can also be used in a clinical setting, its classification as an OTC device and lack of professional administration requirements emphasize its consumer-friendly, non-invasive design for home treatment.
Can the LightStim Anti-Wrinkle OTC Model AAL be reused multiple times, or is it intended for single-use only?
The device is intended for single-use or reusable application, meaning it can be used multiple times if properly maintained. However, the manufacturer does not specify sterilization requirements or reuse guidelines, so users should follow best practices for hygiene and device care to ensure safety and effectiveness.
What regulatory pathway was followed for the FDA clearance of the LightStim Anti-Wrinkle OTC Model AAL, and what does this mean for its safety and equivalence?
The device received FDA clearance via a 510(k) submission (K101190), classified as *substantially equivalent* to a predicate device under regulation 878.4810. This means the FDA determined it has the same intended use and technological characteristics as a previously cleared device, ensuring it meets safety and effectiveness standards for light-based wrinkle reduction treatments.
Are there any specific storage instructions provided for the LightStim Anti-Wrinkle OTC Model AAL, or should it be stored under general household conditions?
The provided data does not specify storage instructions for the device. Since it is intended for over-the-counter use, it is likely designed to be stored under standard household conditions (e.g., room temperature, away from moisture). Always refer to the manufacturer’s included instructions for precise guidance.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC (K101190) — FDA 510 (k ..., LIGHTSTIM ANTI-WRINKLE OTC MODEL AAL OTC 510(k) K101190 - fda.report, fda.innolitics.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K101190 | Class II | Active |
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Manufacturer
- Manufacturer
- Led Intellectual Properties, LLC
Sources (1)
- FDA 510(k) K101190 24 fields · synced Sep 19, 2026