Defensible Efficacy Data for Device Claims
At Validated Claim Support, we conduct a broad range of clinical studies for beauty devices, personal wellness technology, and FDA-regulated medical devices that make skin, hair, or body composition claims. Whether your device uses LED light therapy, microcurrent, radiofrequency, EMS, ultrasound, laser, or mechanical stimulation, we design and execute studies that produce defensible, substantiated efficacy data.
As retailers like Sephora, Ulta, and Best Buy raise the bar on the independent clinical evidence they expect from device brands, a GCP compliant, FDA registered testing partner matters more than ever. Validated Claim Support brings the same rigor applied to pharmaceutical drug studies to the consumer and professional device market.
Why Independent Clinical Testing Matters for Device Brands
Consumer devices that make skin or body claims sit in an increasingly scrutinized regulatory space. The FTC has broadened its oversight of efficacy claims beyond traditional skincare and supplements to include wearable and handheld devices. Claims such as “clinically proven to reduce wrinkles,” “improves skin tone in 8 weeks,” or “increases collagen production” require substantiated, independently conducted data to withstand regulatory and competitive challenge.
An independent, third-party study conducted at an FDA registered facility provides a level of credibility that internal testing alone cannot. Validated Claim Support is privately held, with no ownership ties to any device manufacturer, which makes our data independent and defensible.
Device Types We Test at Validated Claim Support
Our clinical team has experience designing and executing studies for a wide range of device categories.
LED and red light therapy masks and panels (anti-aging, acne, skin rejuvenation)
Microcurrent facial devices (lifting, contouring, collagen stimulation)
Radiofrequency (RF) skin tightening devices
EMS (electrical muscle stimulation) facial and body devices
Ultrasound and ultrasonic skin treatment devices
Laser and IPL devices for hair reduction, skin tone, or vascular claims
Scalp and hair growth devices (LLLT, microneedling, DHT-blocking technology)
Cryotherapy and thermal treatment devices (cooling, depuffing, circulation)
Percussive and vibration therapy devices (muscle recovery, lymphatic drainage)
Wearable skin and scalp health monitors
Filtered showerheads and water treatment devices with skin or hair claims
Oral care devices with whitening or gum health claims
Sample Device Efficacy Claims We Can Substantiate
Skin and Anti-Aging
- Clinically proven to reduce the appearance of fine lines and wrinkles
- Improves skin firmness and elasticity in X weeks
- Increases dermal collagen in X weeks of consistent use
- Reduces the appearance of skin laxity
- Improves skin tone, texture, and radiance
- Reduces the appearance of redness and inflammation
Hair and Scalp
- Clinically shown to improve hair density
- Reduces hair shedding in X weeks
- Supports scalp health and barrier function
- Improves hair thickness, shine, and manageability
Safety and Tolerance
- Clinically tested and shown to be gentle on skin
- Non-irritating, suitable for sensitive skin
- Ophthalmologist tested
- Dermatologist tested and approved
Device-Specific Performance
- Measurably reduces skin surface temperature within X minutes
- Improves skin hydration and barrier function
- Reduces skin surface oil (sebum) by X%
- Demonstrably improves microcirculation at the skin surface
Regulatory Considerations for Device Claim Testing
The regulatory pathway for a device claim study depends on how the device is classified. Cosmetic devices, those making aesthetic, non-medical claims, are generally not required to submit to the FDA as a Class I, II, or III device, but must still substantiate all marketing claims under FTC guidelines.
Devices that make drug-adjacent or medical claims, such as those involving collagen production, acne reduction via a regulated mechanism, or wound healing, may require IRB oversight and formal FDA device registration depending on intended use. Validated Claim Support maintains an active relationship with Allendale Investigational IRB and can facilitate full IRB review when it is required or advisable for your study.
We recommend discussing your intended claims with your regulatory counsel before committing to a study design. Our clinical team is available to consult on study scope, endpoint selection, and regulatory appropriateness before the proposal stage.
How we test
The Four Methods Applied to Device Studies
All four of Validated Claim Support's core testing methods can be applied to device efficacy studies, individually or in combination. Device studies often need a multi-modal approach because their endpoints are more complex than those for a topical product. A single instrument or grading method rarely captures the full scope of what a device does.
Method 1 of 4
Expert Clinical Grading
Expert grading by a trained clinical evaluator is one of the most flexible and widely accepted methods for device efficacy substantiation. Our graders assess visible skin conditions using validated scales and score changes from baseline at each timepoint. For device studies, expert grading is particularly well suited to:
- Wrinkle severity and depth reduction (Fitzpatrick, Lemperle, or Merz grading scales)
- Skin laxity and lifting assessments
- Redness and erythema scoring before and after EMS, radiofrequency, or thermal treatments
- Acne lesion counting and classification for devices making acne-related claims
- Hair density and scalp condition scoring
- Overall skin quality and appearance assessments
Method 2 of 4
Instrumental Evaluations
Instrumental measurements produce direct, objective, percentage-based data that is among the most compelling evidence available for device claim substantiation. Validated Claim Support maintains an extensive library of calibrated biophysical instruments on-site that measure specific skin parameters before and after device use. Instruments commonly used in device studies:
- Corneometer (Courage + Khazaka): skin hydration, for devices claiming moisturization or barrier support
- Tewameter / Vapometer (Courage + Khazaka / Delfin): transepidermal water loss and barrier function, particularly relevant for thermal and photobiomodulation devices
- Cutometer (Courage + Khazaka): skin firmness and elasticity, the standard endpoint for anti-aging device studies
- Laser Doppler (AD Instruments): cutaneous blood flow and microcirculation, used in EMS, thermal, and percussive device studies
- Colorimeter / Minolta Chromameter: skin color and tone changes, for redness, erythema, and pigmentation shifts
- Visioscan (Courage + Khazaka): surface roughness, fine line structure, and skin texture
- Antera 3D (Miravex): multi-spectral 3D imaging of fine lines, wrinkles, and skin topography
- Sebumeter (Courage + Khazaka): skin surface oil, for devices making acne or pore claims
- Dermo (Varenne Technologies): dermal collagen concentration and water content, for collagen stimulation claims
- Ultrasound DermaScan C (Cortex): dermal thickness, a direct measure of collagen structural change over time
- AGE Scanner (Diagnoptics): advanced glycation end-product concentration, for anti-aging and longevity device claims
Method 3 of 4
User Trials and Subjective Questionnaires
Consumer perception data captures the lived experience of using your device, something instrumentation and expert grading cannot fully convey. At VCS, we build structured self-assessment questionnaires into most device study designs to provide the marketing-facing data that resonates with consumers. Common endpoints include:
- Self-perceived skin firmness, lifting, or tightening
- Perceived improvement in skin texture, tone, or radiance
- Satisfaction with ease of use, comfort during treatment, and overall experience
- Willingness to recommend the device to others
- Open-ended qualitative feedback on results noticed over the study period
User trial data combines with instrumental and photographic data to produce a complete claims package, covering both the scientific and the consumer-facing sides of your marketing.
Method 4 of 4
Before and After Photography
Clinically standardized before and after photography is one of the most useful tools in a device brand's marketing. Validated Claim Support operates a custom-built photography studio with controlled lighting, standardized positioning, and multi-angle capture to document real change over a device study timeline. Options include:
- Full-face and targeted-area before and after image sets at each study timepoint
- Polarized, cross-polarized, UV, and standard visible light imaging
- 4K 360-degree video documentation for digital marketing
- Hair density and scalp close-up imaging with measurement overlays
- Side-by-side, split-frame, and animated comparison formats
Photography from a VCS study is ready for direct use in advertising, packaging, and digital marketing without further post-production. The clinical chain of custody and standardized capture protocol make our images defensible as study documentation.
Typical Study Designs for Medical and Beauty Devices
Device studies at VCS are custom-designed for each product and intended claim set. Common frameworks include:
- Single-arm, open-label efficacy studies. Best suited to devices where placebo control is impractical. Baseline serves as the control.
- Randomized, placebo or sham-controlled studies. The gold standard for comparative or superiority claims, using a matched sham device.
- Split-face or split-body comparative designs. Head-to-head comparison within the same participant.
- Crossover designs. Participants use the test and control device at different periods, which reduces variability.
- Single-use or immediate-effect studies. For devices claiming instant results, with timepoints at baseline, immediately after use, and 1 to 4 hours later.
- Multi-week longitudinal studies (4, 8, 12, or 24 weeks). For devices claiming cumulative or progressive improvement over a treatment course.
Study durations, visit frequencies, and participant counts are matched to the strength of claim you intend to make, your device's regulatory pathway, and your budget and timeline. Our clinical team consults on study design before the proposal stage at no cost.
Why Device Brands Choose Validated Claim Support
FDA Registered and Inspected
Our facility meets the regulatory standard required for defensible claim support data.
Independently and Privately Held
No conflicts of interest and no ownership ties to device manufacturers or ingredient suppliers.
ISO 9001:2015 Certified
Validated Claim Support is ISO 9001:2015 certified with TUV Rheinland of North America.
GCP Compliant
Studies are conducted under Good Clinical Practice guidelines.
IRB Access
An active relationship with Allendale Investigational IRB for studies requiring ethical oversight.
Diverse Participant Database
5,000+ active panelists across a full range of Fitzpatrick skin types, ages, and backgrounds in the Teaneck, NJ area.
115+ Years of Combined Team Experience
Clinical expertise across device, skincare, OTC drug, and supplement categories.
Industry-Leading Photography
A custom studio with 4K video and multi-spectral imaging.
Fast Turnaround
Responsive project management from quote through final report.
Expert Clinical Grading
Trained graders score visible changeSupports claims like “Clinically proven to reduce the appearance of fine lines and wrinkles”
Learn more →Biomarkers and Microbiome
Tape strips, swabs and collectionsSupports claims like “Microbiome friendly” and “Won’t disrupt the skin’s natural microbiome”
Learn more →Biophysical Instrumentation
Hydration, TEWL, elasticity, colorSupports claims like “Hydrates by up to 87% in as little as one use”
Learn more →Peer-Reviewed Writing
Clinical and scientific publicationsScientifically validated study summaries for publication in peer-reviewed medical journals
Learn more →Before and After Photography
Controlled, reproducible clinical imagingSupports claims like “Up to a 44% reduction in redness in as little as 2 weeks”
Learn more →Consumer Perception
Panelist questionnaires and self-assessmentSupports claims such as “97% of women agreed their skin felt smoother and more supple”
Learn more →Get a Quote for Your Device Study
Ready to substantiate your device's efficacy claims with independent clinical data? Contact our business development team to discuss your study needs, intended claims, timeline, and budget. We respond to all inquiries within one business day.
Looking for a different claim?
See every claim we substantiate, what it means and how we test it.
Browse all claims