Science & Certifications

The testing behind the Neck & Chest Pro

A light therapy device for the neck and chest, listed with the FDA as a Class II 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 Neck & Chest Pro Light Therapy Mask
Device class
FDA Class II, over-the-counter
FDA status
Listed · Exempt, IL Y
Intended use
Cosmetic use on the neck and chest area to support more youthful-looking skin
Clinical testing
Kosmoscience Group · reports TR-SWV009-25-A-2-R2, -A-4-R2, -A-6-R3
Published
2026-08-25

What the testing shows

    Contents · 10 sections
      §01

      Listed with the FDA as a Class II device

      What this section covers The device's regulatory status, in the exact terms the regulator uses, and what FDA listing means for a device in this category.

      FDA-Listed
      Class II device · Listing: Exempt, IL Y
      Intended for cosmetic use on the neck and chest area
      to support more youthful-looking skin

      The Neck & Chest Pro is an over-the-counter light therapy device intended for cosmetic use on the neck and chest area, to support more youthful-looking skin. It is listed with the FDA as a Class II device, and it is built by an FDA-registered manufacturer under certified medical-device quality systems (§03).

      A note on wording. This device's category is 510(k)-exempt: FDA regulations do not require a premarket 510(k) review for it, so the device is listed with the agency rather than cleared. That is why we say FDA-listed for this product and not FDA-cleared; the two terms describe different pathways, and we use the one that applies. It shares its optical platform (the same four wavelengths, LED architecture and dose) with our Wrinkle Retreat Pro face mask, which holds its own 510(k) clearance for 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 a single three-minute treatment delivers.

      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 Neck & Chest 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.

      §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 Neck & Chest 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, on the neck and chest.

      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 the neck and the chest separately and graded what had changed in each area. 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.
      Study areaNeck and chest.
      SelectionUndamaged skin in the study area, presenting wrinkles and lines, spots, irregular texture, redness and blemishes.
      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 cosmetic products for 48 hours before the study began.

      04.2The three reports

      Report numberIssue dateStudy
      TR-SWV009-25-A-2-R206/03/2026Instrumental analysis: cutometry.
      TR-SWV009-25-A-6-R306/03/2026Expert grading by a dermatologist.
      TR-SWV009-25-A-4-R205/07/2026Consumer 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-2-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: neck and chest separately

      What this section covers A dermatologist examined each participant at the start, at four weeks and at eight weeks, grading the neck and the chest as separate areas. 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-6-R3.

      The figures below show the share of participants in whom the dermatologist observed a visible improvement, reported separately for the neck and the chest.

      Fig. 06.1 · dermatologist grading by area, 4 weeks to 8 weeks Hollow marker: 4 weeks. Solid marker: 8 weeks. Where the figure is identical at both points the two marks are drawn concentrically and labelled “unchanged”, so two readings are never mistaken for one. The axis is fixed at 0–100% and is never truncated. Dark spots and discoloration were graded at 8 weeks.

      Neck

      Chest

      §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-4-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 Neck & Chest 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 Neck & Chest Pro Light Therapy Mask: four wavelengths, 320 LEDs, three minutes a day.

          View the product
          Solawave · Neck & Chest Pro Light Therapy Mask. Listed with the FDA as a Class II device; intended for cosmetic use on the neck and chest area. Clinical results from three reports issued by Kosmoscience Group, 2026. Published 2026-08-25.