Clinical Results & FDA Clearance
Cloakla LED light therapy masks are FDA-cleared Class II medical devices. This page documents the regulatory clearance, the clinical research behind each wavelength we deliver, and the dosimetry that makes Cloakla a medical-grade home device rather than a consumer gadget.
FDA Class II clearance
Both the Cloakla C16 and K11 are cleared as FDA Class II medical devices under the U.S. Food and Drug Administration's classification for light-based therapy devices intended for skin treatment. Class II means the device has demonstrated substantial equivalence to a predicate device with established safety and effectiveness.
You can verify Cloakla's clearance status in the FDA 510(k) Premarket Notification Database. Search for "Cloakla" or contact info@cloakla.com for the specific clearance numbers (K-numbers).
Note: This page links to the FDA database for verification. Clearance documentation is updated as new product variants are registered.
Why FDA clearance matters for LED masks
The at-home LED mask category is largely unregulated. Many devices sold online are consumer electronics, not medical devices — meaning they don't have to meet:
- Irradiance verification (light output is what the brand claims)
- Wavelength accuracy (LEDs actually emit the nm range listed)
- Eye safety testing (especially for blue light)
- Quality systems regulation (manufacturing under 21 CFR Part 820)
- Adverse event reporting
FDA Class II clearance means an independent regulatory body has verified all of the above for Cloakla devices.
Wavelengths: the clinical research
Every wavelength Cloakla emits is supported by peer-reviewed dermatology research. Below is a summary of the published evidence base for each wavelength delivered by the C16 and K11.
633 nm + 660 nm Red (collagen, fine lines)
Red light at 630–660 nm is the most-studied wavelength range for skin rejuvenation. Multiple randomized clinical trials have demonstrated significant improvements in skin firmness, wrinkle depth, and dermal collagen density after 8–12 weeks of treatment. Mechanism: photo-biomodulation activates cytochrome c oxidase in mitochondria, increasing cellular ATP and fibroblast activity.
Representative research: Wunsch & Matuschka (2014), Photomedicine and Laser Surgery — randomized controlled trial of red and near-infrared LED for skin rejuvenation.
830 nm + 850 nm Near-Infrared (deep tissue, healing)
Near-infrared penetrates deeper than visible red light (up to ~5 mm vs 1–2 mm). Used clinically for wound healing, post-procedure recovery, and deep tissue inflammation. Research supports its role in calming sub-clinical inflammation and supporting tissue repair.
590 nm Amber (pigmentation, brightening)
Amber light at 590 nm reduces melanin production and fades post-inflammatory hyperpigmentation. Used in dermatology clinics for melasma and uneven tone, often paired with red light for synergistic effect.
415 nm Blue (acne bacteria)
415 nm blue light specifically targets Propionibacterium acnes (now reclassified as Cutibacterium acnes), the bacterium implicated in inflammatory acne. The American Academy of Dermatology recognizes blue light therapy as an evidence-based adjunct treatment for mild-to-moderate acne.
520 nm Green (redness, capillaries)
Green light at 520 nm is absorbed by hemoglobin, making it useful for reducing the appearance of redness, broken capillaries, and post-laser flushing. Used clinically alongside other modalities for rosacea management.
Dosimetry: irradiance and dose
The clinical effect of LED light depends on three variables: wavelength accuracy, irradiance (mW/cm²), and dose (joules/cm² delivered over time). Underpowered devices fail to reach therapeutic thresholds even at long session lengths.
| Metric | Cloakla C16 | Cloakla K11 | Clinical threshold |
|---|---|---|---|
| Irradiance | 50+ mW/cm² | 60+ mW/cm² | 30+ mW/cm² (peer-reviewed minimum) |
| 10-min dose | ~30 J/cm² | ~36 J/cm² | 10–60 J/cm² (therapeutic range) |
| Wavelength tolerance | ±5 nm | ±5 nm | ±10 nm |
Both Cloakla devices exceed the clinical threshold across all metrics, which is what makes a 10-minute session at home equivalent to a longer clinic session with weaker consumer devices.
Safety profile
- Non-UV: No skin cancer risk. LED emits visible and near-infrared light, never ultraviolet.
- Non-thermal: Treatment temperature stays at or near skin temperature. No burn risk.
- Eye-safe: Included eye-protection pads block direct retinal exposure to high-intensity LEDs (especially blue 415 nm).
- Pregnancy: LED is generally considered safe during pregnancy. We still recommend confirming with your OB/GYN.
- Skin sensitivity: Safe for sensitive skin, rosacea, melasma, post-procedure, and post-laser recovery.
- Photosensitizing medication: If you take Accutane (isotretinoin), tetracycline antibiotics, or other photosensitizers, consult your dermatologist before use.
What the 4.9★ / 12,000+ review rating means
Cloakla maintains a 4.9 / 5 average rating across 12,000+ verified buyer reviews. These are self-reported satisfaction outcomes from real users, not a clinical trial endpoint. Individual results vary based on consistency of use, baseline skin condition, age, and lifestyle factors.
We don't publish clinical trial data we don't own. If you've seen brands quote "% improvement in fine lines" without naming the study, source, or sample size, that's marketing — not science. We're working on a peer-reviewed user outcomes study for 2026. Email us if you'd like to participate.
Questions about clinical claims?
Email info@cloakla.com for:
- Specific FDA 510(k) clearance numbers (K-numbers)
- Irradiance test reports
- Wavelength spectroscopy data
- Quality management system documentation
- Clinical research bibliography