Science & Certifications

The testing behind the 4-in-1 Skincare Wand

An FDA-cleared Class II medical device combining four technologies (red light therapy, galvanic current, therapeutic warmth and vibrational massage), 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 4-in-1 Skincare Wand
Device class
FDA Class II, over-the-counter
Clearance
510(k) K232863
Cleared indication
Facial and neck stimulation; treatment of wrinkles on the face using red light
Clinical testing
Kosmoscience Group · reports TR-SWV002-24-A-2-R1, TR-SWV002-24-A-1-R0
Published
2026-08-25

What the testing shows

    Contents · 9 sections
      §01

      An FDA-cleared medical device

      What this section covers What the FDA clearance is, exactly what it covers, and why that puts the 4-in-1 Skincare Wand in a different category from most skincare tools.

      510(k) K232863
      FDA-cleared Class II medical device
      Indication: facial and neck stimulation, and the treatment of wrinkles
      on the face using red light

      To earn this clearance we submitted the 4-in-1 Skincare Wand to the U.S. Food and Drug Administration and demonstrated that it is substantially equivalent to devices already legally cleared for the same uses. The cleared indication has two parts: stimulation of the face and neck, and the treatment of wrinkles on the face using red light.

      This matters because most skincare wands and massagers 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.

      §02

      What the device delivers

      What this section covers The wand's four technologies (red light, galvanic current, therapeutic warmth and vibrational massage) with the measured specification of each.

      Fig. 02.1 · red light emission specification One wavelength band, centred at 630nm. Bar width shows the ±10nm centre-wavelength tolerance; the lighter cap shows the ±10% irradiance tolerance. The strip beneath marks the part of the spectrum visible to the human eye. Colour on this page is reserved for light the device actually emits and is used nowhere else.

      Red light therapy

      SpecificationValueWhat it means
      Wavelength630nm ±10nmRed light. The wand emits one wavelength; each of its 7 dual-core emitters houses two 630nm sources.
      Irradiance55 mW/cm² ±10%How much light power reaches a square centimetre of skin at any moment.
      Fluence9.9 J/cm² per areaThe total light dose delivered to one treatment area over a full three-minute session.
      Emitters14 LEDs
      7 dual-core      		Seven emitters, each housing two 630nm LEDs in a single package.

      The other three technologies

      TechnologySpecificationWhat it means
      Galvanic current~200 μA at ~10.5 HzA gentle, low-level electrical current (about two ten-thousandths of an ampere) of the kind used in iontophoresis to help topical products absorb (see §07).
      Therapeutic warmthMax 41°C / 105.8°FThe treatment head warms to no more than 41°C: warm to the touch, capped below temperatures that stress skin.
      Vibrational massage~12,000 rpmA high-frequency micro-vibration delivered through the treatment head as it glides.

      Treatment

      ParameterValueWhat it means
      Treatment time3 min per area
      12 min total      		Three minutes on each area. The suggested areas are the forehead, the right side of the face, the left side of the face, and the neck.
      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.

      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.

      §03

      Safety and compliance testing

      What this section covers Every standard the 4-in-1 Skincare Wand 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 4-in-1 Skincare Wand 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 wand, 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 wand and its serum, and how their skin was assessed.

      We commissioned Kosmoscience Group, an independent third-party contract research organisation, to evaluate the 4-in-1 Skincare Wand used together with the LightBoost Wand Activating Serum. Thirty-three participants aged 41 to 68 used the products at home once a day, five days a week, over eight weeks.

      Skin on the face and neck was assessed at the start, immediately after the first use, at four weeks and at eight weeks. A dermatologist examined each participant and graded what had changed, and participants answered a questionnaire about what they noticed. Those two sets of results are reported in Sections 05 and 06.

      04.1The study record

      ParameterRecord
      Conducted byKosmoscience Group, an independent third-party contract research organisation.
      Products testedThe 4-in-1 Skincare Wand used with the LightBoost Wand Activating Serum.
      Participants33, ages 41 to 68.
      Study areaFace and neck.
      SelectionUndamaged skin in the study area, presenting wrinkles and expression lines, periorbital hyperpigmentation, facial blemishes and irregular skin tone.
      RegimenOnce per day, 5 times per week.
      SettingHome use.
      Assessment pointsBaseline, after first use, 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 gave written informed consent and underwent a clinical examination against the study's inclusion and non-inclusion criteria, and discontinued cosmetic products on the study area for 48 hours before the study began.

      04.2The two reports

      Report numberIssue dateStudy
      TR-SWV002-24-A-2-R111/14/2024Expert grading by a dermatologist.
      TR-SWV002-24-A-1-R011/07/2024Consumer perception questionnaire.
      §05

      Assessed by a dermatologist

      What this section covers A dermatologist examined each participant at the start of the study, immediately after the first use, 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 of the wand used with the LightBoost serum, at baseline, after first use, 4 weeks and 8 weeks. Report TR-SWV002-24-A-2-R1.

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

      Fig. 05.1 · dermatologist grading, first use to 8 weeks Small hollow marker: after first use. Hollow marker: 4 weeks. Solid marker: 8 weeks. Where the figure is identical at 4 and 8 weeks 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. Two attributes were graded from the very first use; the other four are reported at 8 weeks.
      §06

      Reported by participants

      What this section covers What the people using the wand and serum said: how the pair 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 on the wand used with the LightBoost serum, completed after first use, at 4 weeks and at 8 weeks. Report TR-SWV002-24-A-1-R0.

      The figures below show the share of participants who agreed with each statement about the wand and serum.

      After first use

      Skin appearance over eight weeks

      §07

      Published research on the wand's technologies

      What this section covers Independent published research on each of the wand's four technologies, and the LightBoost serum's own certifications. These are studies by other researchers on other devices, included as background on the technologies; they are not studies of this wand.

      Published research · peer-reviewed papers on red LED light therapy, therapeutic warmth, facial massage and galvanic current.

      07.1Red light therapy (630–633nm)

      Published findings on red LED light therapy devices as a category, from four clinical papers.

        Solawave's technology-claims file for the wand also cites further red-light research at 630nm: references [5] to [10] below.

        07.2The supporting technologies

        07.3The LightBoost Wand Activating Serum

        Our clinical testing in Sections 05 and 06 evaluated the wand used together with this serum, which is designed to conduct the galvanic current and give the wand its glide. The serum carries its own certifications.

        References

          §08

          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.

          §09

          Terms used on this page

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

          The 4-in-1 Skincare Wand: red light therapy, galvanic current, therapeutic warmth and vibrational massage, three minutes per area.

          View the product
          Solawave · 4-in-1 Skincare Wand. FDA-cleared under 510(k) K232863 for facial and neck stimulation and the treatment of wrinkles on the face using red light. Clinical results from two reports issued by Kosmoscience Group, November 2024. Published 2026-08-25.