Science & Certifications

The testing behind the Wrinkle Retreat Pro

An FDA-cleared Class II medical device, tested against – international standards and evaluated over eight weeks by an independent research organisation. Every test, every standard and every result is published here in full.

Product
Solawave Wrinkle Retreat Pro Light Therapy Face Mask
Device class
FDA Class II, over-the-counter
Clearance
510(k) K252983
Cleared indication
Treatment of full-face wrinkles
Clinical testing
Kosmoscience Group · reports TR-SWV009-25-A-1-R2, -A-3-R2, -A-5-R2
Published
2026-07-31

What the testing shows

    Contents · 9 sections
      §01

      An FDA-cleared medical device

      What this section covers What the FDA clearance is, what it covers, and why that puts the Wrinkle Retreat Pro in a different category from most LED masks.

      510(k) K252983
      FDA-cleared Class II medical device
      Indication: treatment of full-face wrinkles

      To earn this clearance we submitted the Wrinkle Retreat Pro to the U.S. Food and Drug Administration and demonstrated that it is substantially equivalent to a device already legally cleared for the same use. The submission covers the device's design, its light output, and its safety testing.

      This matters because most LED masks on the market are sold as cosmetic devices and carry no FDA clearance at all. A 510(k) clearance means the device has been through the FDA's medical device pathway and is regulated as a Class II medical device.

      A note on wording. Devices in this category are FDA-cleared, not FDA-approved. Clearance and approval are two different FDA pathways, and Class II devices like this one go through clearance. We use the word the regulator uses. Like every light therapy mask, the clearance names one intended use: in our case, full-face wrinkles.

      §02

      What the device emits

      What this section covers The four wavelengths the mask produces, how much light power each one contributes, and the dose delivered in a single three-minute treatment.

      Fig. 02.1 · emission specification Bar width shows the ±5nm centre-wavelength tolerance; the lighter cap on each bar shows the ±20% irradiance tolerance. The wavelength axis is broken between 680 and 800nm, and the scale is identical on both sides of the break, so no band is compressed or exaggerated. 830nm is drawn as an outline rather than given a colour, because near-infrared light sits beyond the range of human vision. Colour on this page is reserved for light the device actually emits and is used nowhere else.
      Irradiance measured at the emitting surface. The four values sum to the total output of 65 mW/cm².
      WavelengthNameIrradianceVisible to the eye
      SpecificationValueWhat it means
      Total irradiance65 mW/cm²How much light power reaches a square centimetre of skin at any moment.
      Fluence11.7 J/cm²The total dose delivered over one full treatment: power multiplied by time.
      Treatment time3 minutesThe length of one session.
      Use frequency3–5 days per weekOur clinical testing was carried out at five sessions per week. Increase beyond the labelled frequency only as recommended by your physician.
      Emitters320 LEDs
      160 dual-core      		80 emitters pair 630nm with 830nm; 80 pair 605nm with 660nm. Each dual-core emitter houses two wavelengths in one package.

      Light output was verified by irradiance testing under IEC 62471:2006, with the device fully charged and the measuring probe held close to the emitting surface. Measured values were consistent with the specification above at all four wavelengths.

      §03

      Safety and compliance testing

      What this section covers Every standard the Wrinkle Retreat Pro was tested against, what each standard checks, and the result. Standards are printed with their version and amendment years so any entry can be looked up independently.

      03.1Is the light safe near my eyes?

      Light output was measured against IEC 62471, the international standard for optical radiation hazard. That standard sorts light sources into four groups by hazard level. The Wrinkle Retreat Pro was placed in the lowest one.

      Fig. 03.1 · photobiological classification under IEC 62471:2006 Exempt Group is the lowest of the four hazard classifications the standard assigns. It means the light source poses no photobiological hazard under the conditions of the test.

      Exempt Group is a classification of the light source itself. For guidance on how to use the mask (including whether to keep your eyes open or closed), follow the instructions supplied with the product.

      §04

      How we tested it

      What this section covers Who ran our clinical testing, who took part, how they used the device, and how their skin was assessed.

      We commissioned Kosmoscience Group, an independent third-party contract research organisation, to evaluate the Wrinkle Retreat Pro. Thirty-two participants aged 37 to 70 used the device at home for three minutes a day, five days a week, over eight weeks.

      Their skin was assessed three ways at three points: at the start, at four weeks and at eight weeks. An instrument measured skin firmness and elasticity. A dermatologist examined each participant and graded what had changed. And participants themselves answered a questionnaire about what they noticed. Those three sets of results are reported in Sections 05, 06 and 07.

      04.1The study record

      ParameterRecord
      Conducted byKosmoscience Group, an independent third-party contract research organisation.
      Participants32, ages 37 to 70.
      SelectionUndamaged facial skin in the study area, presenting wrinkles and expression lines, periorbital hyperpigmentation, facial blemishes and irregular skin tone.
      Regimen3 minutes per day, 5 times per week, on clean dry skin.
      SettingHome use.
      Assessment pointsBaseline, day 28 (4 weeks), day 56 (8 weeks).
      Ethics and consentPlanned and conducted according to Resolution 466/12 of the National Council of Health on Regulatory Guidelines and Standards for Research Involving Humans. All participants signed an Informed Consent Form and underwent a clinical examination against the study's inclusion and non-inclusion criteria, and discontinued facial cosmetics for 48 hours before the study began.

      04.2The three reports

      Report numberIssue dateStudy
      TR-SWV009-25-A-1-R206/03/2026Instrumental analysis: cutometry.
      TR-SWV009-25-A-5-R206/03/2026Expert grading by a dermatologist.
      TR-SWV009-25-A-3-R206/02/2026Consumer perception questionnaire.
      §05

      Measured by instrument: firmness and elasticity

      What this section covers An instrument, not a person, measured how firm and how elastic each participant's skin was. A Cutometer applies gentle suction to a small patch of skin and records how far the skin is drawn in and how much of that movement springs back.

      Measured by instrument · Cutometer® (CKelectronics, Germany). Report TR-SWV009-25-A-1-R2.

      Fig. 05.1 · improvement measured at eight weeks Firmness is measured by the Uf (R0) parameter and elasticity by Ur/Uf (R7). Improvement means the parameter moved in the favourable direction: for firmness the skin was drawn in less far under suction, and for elasticity a greater share of that movement was recovered. Each figure is the largest improvement recorded, measured against each participant's own baseline reading.
      Share of participants whose readings improved, at four weeks and at eight weeks.
      MeasureParameter4 weeks8 weeks
      Skin firmnessUf (R0)100% of participants100% of participants
      Skin elasticityUr/Uf (R7)100% of participants100% of participants
      §06

      Assessed by a dermatologist

      What this section covers A dermatologist examined each participant at the start of the study, at four weeks and at eight weeks, and graded whether each attribute had visibly changed. Expert clinical grading by a dermatologist is one of the established methods for evaluating how a skincare device performs.

      Assessed by a dermatologist · clinical grading at baseline, 4 weeks and 8 weeks. Report TR-SWV009-25-A-5-R2.

      The figures below show the share of participants in whom the dermatologist observed a visible improvement.

      Fig. 06.1 · dermatologist grading, 4 weeks to 8 weeks Hollow marker: 4 weeks. Solid marker: 8 weeks. Where the figure is identical at both timepoints the two marks are drawn concentrically and labelled “unchanged”, so that two readings are never mistaken for one. The axis is fixed at 0–100% and is never truncated. Every attribute the dermatologist graded either held at 100% or improved between the two assessments.
      §07

      Reported by participants

      What this section covers What the people using the mask said about it: how it felt to use from the first session, and what they noticed in their skin over eight weeks.

      Reported by participants · five-point Likert scale questionnaire, completed after first use, at 4 weeks and at 8 weeks. Report TR-SWV009-25-A-3-R2.

      The figures below show the share of participants who agreed with each statement.

      After first use

      Skin appearance · asked at both 4 and 8 weeks

      Skin appearance · asked at 8 weeks

      Would they recommend it?

      §08

      Published research on red and near-infrared light

      What this section covers Independent published research into red and near-infrared LED light therapy as a technology. These are studies by other researchers on other devices, included as background on the wavelengths the Wrinkle Retreat Pro uses; they are not studies of this device.

      Published research · four peer-reviewed papers, 2005–2011, on 630–633nm and 830nm LED therapy.

        References

          §09

          All results at a glance

          What this section covers Every clinical result on this page in one table, with the report it came from, how it was assessed and when, so any figure can be traced to its source.

          §10

          Terms used on this page

          What this section covers Plain definitions for the technical terms and units used above.

          The Wrinkle Retreat Pro Light Therapy Face Mask: four wavelengths, 320 LEDs, three minutes a day.

          View the product
          Solawave · Wrinkle Retreat Pro Light Therapy Face Mask. FDA-cleared under 510(k) K252983 for the treatment of full-face wrinkles. Clinical results from three reports issued by Kosmoscience Group, June 2026. Published 2026-07-31.