FDA Status and Real Results: How Top LED Devices Stack Up in 2025
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Red light therapy isn’t just a wellness trend anymore, it’s a booming industry backed by science and clinical validation. In June 2025, the New York Post published a comparative review of four leading LED devices, Gleam Mini, CurrentBody, Kineon, and Mito highlighting not only their design and results but also their FDA clearance status, a crucial factor for safety and credibility.
With so many devices on the market, consumers want to know: which ones are truly worth it? Let’s break down what the review uncovered and what it means for your skin and health.
09/19/2025 – 4 min read
Why FDA Status Matters
The FDA (Food and Drug Administration) clearance is more than a marketing label, it ensures that a device has been tested for safety, efficacy, and clinical standards.
According to experts at Stanford Medicine and UCLA Health using non-cleared devices may still deliver results, but the lack of regulation raises questions about consistency and long-term safety.
In simple terms: an FDA-cleared device gives you peace of mind that you’re investing in a product that meets rigorous U.S. medical standards.
The Four Devices Compared
1. Gleam Mini
The Gleam Mini has quickly gained attention as a compact, travel-friendly LED mask. While praised in outlets like Marie Claire for its sleek design and accessibility, it currently does not have FDA clearance. Experts note that while it may provide surface-level benefits, more clinical validation is needed before it can stand alongside its competitors.
2. CurrentBody LED Mask
One of the most widely recognized beauty LED devices, the CurrentBody LED Mask has been featured across global media for its anti-aging claims. Importantly, it holds FDA clearance for home use, confirming both its safety and efficacy. The New York Post notes that its ergonomic design and proven track record make it a strong option for consumers prioritizing skin rejuvenation.
3. Kineon Move+
Designed originally for pain relief and joint recovery, the Kineon Move+ is a different kind of LED device. According to Utah Health it uses red and near-infrared light to reduce inflammation and support tissue healing. The New York Post highlights its FDA-cleared status, making it a trusted solution not just for athletes but also for anyone dealing with chronic pain or injury recovery.
4. Mito Red Light Panels
The Mito range is known for its high-powered panels, designed for whole-body sessions. Unlike the smaller, beauty-focused devices, these panels target broader health benefits, from muscle recovery to energy optimization. As of June 2025, Mito panels are not FDA cleared, but they continue to be popular among wellness enthusiasts and biohackers, supported by a growing library of independent studies.
Expert Insights
According to dermatologists cited in the New York Post and Wikipedia’s overview of red light therapy, FDA clearance should be considered a baseline requirement for those new to LED treatments. However, lack of clearance doesn’t necessarily mean a device is unsaf, it may simply mean the manufacturer hasn’t yet pursued or obtained FDA recognition.
Clinical experts emphasize that consistency and correct use are just as important as the device itself. Even FDA-cleared devices require regular sessions over weeks to achieve noticeable results.
What This Means for Consumers
- If safety is your top priority: Devices like CurrentBody and Kineon stand out thanks to FDA clearance.
- If budget and portability matter: Gleam Mini offers accessibility but with fewer clinical validations.
- If you want full-body benefits: Mito panels deliver intensity and scale, though without FDA clearance.
The bottom line? FDA status is a key marker of trust, but effectiveness also depends on how consistently and correctly you use the device.
Conclusion
The 2025 New York Post review confirms what health institutions like Stanford and UCLA Health have long stressed: red light therapy is more than a beauty trend, it’s a legitimate health tool when backed by science.
Whether you’re looking to smooth fine lines, recover from workouts, or ease chronic pain, knowing the FDA status and scientific support of your chosen device helps you make a confident, informed decision.
At Redivea, we believe in combining aesthetic care with real science—bringing you tools that are not only beautiful but also effective.
📖 Sources:
-New York Post (June 2025) – Comparative review of Gleam Mini, CurrentBody, Kineon, Mito
- Stanford Medicine – Light therapy research insights
- UCLA Health – Red light therapy guidance
- Utah Health – Clinical applications of photobiomodulation
- Marie Claire – Beauty device reviews
- Wikipedia – Low-level light therapy overview
