Compliance

Every claim here has a document behind it.

Below is the actual document set: directive, standard, issue date and the models each one covers. Where a model is not covered, we say so instead of sending a generic certificate.

Request the document pack See model coverage
Quality control station on the production line
The document set

What exists, under which standard, for which models.

Test reports are issued against a sample, not against a production run. The model list on each certificate is the part most suppliers leave out - it is the first thing on this page.

DocumentDirective / standardModels coveredIssued
CE - EMCEMC Directive 2014/30/EU
EN IEC 55014-1/-2, EN IEC 61000-3-2/-3		RB-051, RB-071, RB-008J, RB-008 series, RB-061, RB-066Jul 2025
CE - RoHS2011/65/EU + (EU) 2015/863
IEC 62321 series		RB-051, RB-071, RB-008J, RB-008 series, RB-061, RB-066Jul 2025
UK - RoHSUK RoHS Regulations SI 2012/3032
BS EN 62321 series		RB-008 through RB-082 seriesDec 2024
US - FCCFCC Part 15 Subpart B, Supplier's Declaration of Conformity
ANSI C63.4:2014		RB-008, RB-030, RB-081Nov 2024
Photobiological safetyIEC 62471:2006 - classified Exempt GroupRB-008, RB-030, RB-081Nov 2024
Handheld - EMC / FCC / RoHSEN IEC 55014-1/-2, FCC Part 15B, RoHS 2.0DYM-063Nov 2024
Japan - PSEJ55014 (EMC)DYM-063Nov 2024
Battery cellIEC 62133 (CB scheme), UL, KC18650 1200mAh cell used across the rangeon file
ISO 9001:2015Quality management systemFacility-widevalid to Jan 2029
ISO 13485:2016Medical device quality management systemFacility-widevalid to Jan 2029
FDAEstablishment registration, 510(k)-exempt listing (product code ISA)LED face mask familyexpires 31 Dec 2026
By model

What is on file for the models on this site.

A dash is not a mistake. It means no document for that model is in the current pack - ask and we will give you the status and the date a report is expected, rather than an old certificate for a different model.

ModelCE-EMCRoHSFCCIEC 62471PSEFDA listed
RB-051YesYes---Yes
RB-071YesYes---Yes
RB-008YesYesYesYes-Yes
RB-008JYesYes---Yes
RB-065-02-----Yes
DYM-063YesYesYes-Yes-
DYM-024 / 046 / 078 / 079------
Reading the FDA paperwork

Registered is not the same word as approved.

Most supplier pages blur this line. Buyers who check will find the difference, so it is worth being precise up front.

What we can say

FDA establishment registration is currentThe manufacturing facility holds an active establishment registration, valid to 31 December 2026.
The devices are listed with FDALED face mask devices are listed under a 510(k)-exempt Class II product code (ISA), which is the correct route for this device type.
Documentation is available to your QA teamYour regulatory contact can review the registration and listing documents before you place an order.

What we do not claim

No 510(k) clearance for LED masksThese devices are 510(k)-exempt. We do not claim clearance, and no premarket notification number applies to them.
No "FDA approved" wordingThe FDA does not approve devices of this type, and it does not issue certificates of registration. Any "FDA certificate" is issued by a consultancy, not by the agency.
No medical claimsMarketing language describes cosmetic use only. Therapeutic claims would change the regulatory route entirely.
Verification

How to check all of this yourself.

We would rather you verified than trusted the page.

01

Ask for the pack

Full scans, certificate numbers and issuing laboratory names are released after an NDA, because they carry the manufacturing entity's details.

Request the pack
02

Query the laboratory

Every report has an issuer and a report number. Your compliance team can query the laboratory directly to confirm it is genuine and unaltered.

03

Match the model, not the brand

Check that the model number on the certificate is the model on your purchase order. A certificate for a sister model does not cover yours.

Request Certificate Copies

Tell us which documents you need and your destination market. We send the relevant certificates and confirm any market-specific requirements.

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