P.s. I Love You · Model RB-051
Documents & Certificates
Every claim traces to a document.
This is the complete file we hold on the mask as it is built today: United States clearance, Australian and Canadian medical device licensing, European CE conformity, United Kingdom UKCA conformity and the United States radio test report. Eight documents, all issued to the manufacturer. Each card opens the original PDF exactly as the authority or the laboratory issued it — nothing summarised, nothing redrawn. What we do not hold is listed further down, by name.
Medical device clearances & licences
Three national authorities have reviewed this device family. Each authorisation is valid only in the country that issued it.
510(k) Clearance K253712
Clearance letter and 510(k) summary from the US Food and Drug Administration. Class II, product codes OHS, OLP and ILY. Cleared indications: full-face wrinkles (red, and red with infrared), mild to moderate inflammatory acne (blue, and red with blue), and topical heating (infrared).
View PDF → TGA · AustraliaARTG Inclusion 524063
Australian Register of Therapeutic Goods certificate for a blue/red/infrared phototherapy lamp, Medical Device Included Class IIa, GMDN 62202. The manufacturer named on the entry is Shenzhen Rainbow Technology.
View PDF → Health CanadaMedical Device Licence 115038
Class 2 family licence issued under Section 36 of the Canadian Medical Devices Regulations for “LED Light Therapy Mask”. Canadian market authorisation only — see the note below.
View PDF →European conformity — CE
Low Voltage Directive 2014/35/EU, EMC Directive 2014/30/EU and the RoHS Directive 2011/65/EU as amended. Main test model RB-051, with the rest of the family listed on each certificate.
Low Voltage Directive Certificate
Conformity with LVD 2014/35/EU, tested to EN 60335-1:2012/A15:2021, EN 60335-2-17:2013/A2:2021 and EN 62233:2008. This is an electrical-safety assessment; it is not an optical-safety assessment.
View PDF → CE · EMCElectromagnetic Compatibility Certificate
Conformity with EMC Directive 2014/30/EU, tested to EN IEC 55014-1:2021, EN IEC 55014-2:2021, EN IEC 61000-3-2:2019/A2:2024 and EN 61000-3-3:2013/A2:2021.
View PDF → RoHS 2.0RoHS Certificate of Conformity
Conformity with RoHS Directive 2011/65/EU Annex II as amended by (EU) 2015/863, tested by the IEC 62321 series of methods — lead, cadmium, mercury, hexavalent chromium, PBB, PBDE and the four restricted phthalates.
View PDF →United Kingdom — UKCA
The British conformity route, assessed separately from the European one.
The remote control — radio testing
The mask is operated by a handheld remote that transmits at 433.92 MHz. Radio equipment is regulated separately from the mask itself. This report covers the United States.
Not in our file yet
These documents are not in our hands today. We list them by name, so you can see exactly what is missing instead of having to guess from what is absent. Each one is published here the day we hold it, and not a day before.
Photobiological Safety Report
IEC 62471, photobiological safety of lamps and lamp systems, is one of the standards listed in the FDA submission above. The manufacturer has confirmed the report to us: DE25070016, issued by STC (Guangdong) Company Limited on 17 November 2025, with model RB-061 named on its cover. We hold that cover page. The full 33-page report is confidential to the manufacturer, so we cannot publish it here.
Confirmed by the manufacturer — not publishableDeclarations of Conformity, EU and UK
The signed manufacturer declarations that the CE and UKCA marks actually rest on. The supporting test certificates are published above; the declarations themselves sit with the manufacturer.
Not held — requested from the manufacturerEuropean Radio Equipment File
EN 300 220, EN 301 489 and the human-exposure standards for the 433.92 MHz remote. The FCC report above covers the United States only; Europe and the United Kingdom need their own file.
Not held — requested from the manufacturerLithium Battery Transport File
UN 38.3 test report and the battery safety data sheet. Air carriers require both before a rechargeable device ships.
Not held — requested from the manufacturerQuality Management System Certificate
Certification of the factory’s quality system for medical devices. Requested from the manufacturer; not in our file.
Not held — requested from the manufacturerReports Behind the CE and UKCA Certificates
Each certificate above states that it is based on a single evaluation and is to be read together with its test report. Those underlying reports have been requested.
Not held — requested from the manufacturerManufacturer Specification Sheet
One written specification on manufacturer letterhead — wavelengths, emitter count, irradiance and runtime — so that every number we publish has a signed source behind it.
Not held — requested from the manufacturerUAE Conformity Assessment
Emirates conformity assessment for the UAE market. In preparation — not yet issued. It will be published here the day it exists, not before.
Not yet issuedUAE Radio Type Approval
Type approval for the 433.92 MHz remote control from the UAE Telecommunications and Digital Government Regulatory Authority. In preparation — not yet issued.
Not yet issuedThe research we cite
When we refer to published evidence for light therapy on skin, these are the papers we mean. Each link goes to the record on PubMed, the US National Library of Medicine index, so you can read the abstract and follow it to the journal yourself. These trials studied LED and low-level light phototherapy devices in general — they were not conducted on this product, and we do not present them as clinical results for the beauty mask.
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Randomised controlled trial · 2007
A prospective, randomized, placebo-controlled, double-blinded, and split-face clinical study on LED phototherapy for skin rejuvenation
Lee SY, Park KH, Choi JW, et al. Journal of Photochemistry and Photobiology B: Biology. 2007;88(1):51–67. Clinical, profilometric, histologic, ultrastructural and biochemical evaluation across three treatment settings.
Read on PubMed → -
Clinical study · 2006
Combined 633-nm and 830-nm LED treatment of photoaging skin
Goldberg DJ, Amin S, Russell BA, et al. Journal of Drugs in Dermatology. 2006;5(8):748–753.
Read on PubMed → -
Systematic review & meta-analysis · 2023
Utilization of light-emitting diodes for skin therapy: systematic review and meta-analysis
Ngoc LTN, Moon JY, Lee YC. Photodermatology, Photoimmunology & Photomedicine. 2023;39(4):303–317.
Read on PubMed →
Missing a document, or need one certified for import? Email info@peak4beauty.com and we will get it from the manufacturer.
See also the compliance summary and the FAQ.
