Compliance, Safety & Regulatory Information
At Brightside Longevity Limited, safety, traceability, and regulatory integrity are central to our product offering.
Our Core Series light systems (Core 300, Core 750, Core 1500) are manufactured under internationally recognised electrical and quality management standards and are certified for sale in Australia, New Zealand, the United States, and the European Union under applicable frameworks.
Below is a summary of the certifications and regulatory position of the Core Series.
Model Identification & Certification Traceability
The Core Series models correspond to the manufacturer’s certified model numbers as follows:
| Core Series (Brand Name) | Manufacturer Model |
|---|---|
| Core 300 | RDPRO300 |
| Core 750 | RDPRO750 |
| Core 1500 | RDPRO1500 |
All certifications and test reports referenced on this page apply to the corresponding manufacturer model numbers listed above.
Australia & New Zealand Electrical Compliance (RCM)
The Core Series is certified under the Global-Mark Electrical Product Safety Certification Scheme (System 1 Approval) and complies with:
-
AS/NZS 60598.1
-
AS/NZS 60598.2.1
-
Fixed general-purpose luminaire standards
This certification authorises application of the Regulatory Compliance Mark (RCM) in Australia and New Zealand.
The certification confirms compliance with:
-
Electrical construction requirements
-
Insulation and earthing (Class I)
-
Temperature limits
-
Mechanical safety
-
Continuous operation safety
These devices are rated 100–240V AC, 50/60Hz.
European Union (CE Compliance)
The Core Series complies with applicable European directives including:
-
EMC Directive (2014/30/EU)
-
Low Voltage Directive (2014/35/EU)
-
RoHS Directive (2011/65/EU & 2015/863)
Testing includes compliance with relevant standards such as:
-
EN 55015 (EMC emissions)
-
EN 61547 (EMC immunity)
-
EN 60335 series (electrical safety)
-
EN 62321 series (RoHS material compliance)
CE marking confirms conformity with EU electrical safety and electromagnetic compatibility requirements.
United States Compliance
FDA Establishment Registration
The manufacturer is registered with the U.S. Food and Drug Administration (FDA), and the corresponding devices are listed under the applicable product code for LED therapy light devices.
Important clarification:
FDA establishment registration and device listing do not constitute FDA approval. Registration does not imply endorsement or evaluation by the FDA.
Medical Electrical Safety Standards
Select Core Series models (manufacturer models RDPRO1000 and RDPRO1500) have been tested to internationally recognised medical electrical safety standards, including:
-
ANSI/AAMI ES60601-1
-
CSA C22.2 No. 60601-1
-
IEC 60601-2-57 (Non-laser light source equipment for therapeutic and aesthetic applications)
These standards govern electrical safety, essential performance, and usability requirements for professional-use electrical equipment.
Quality Management & Manufacturing Controls
The manufacturer operates under:
-
ISO 13485:2016 certified Quality Management System
-
MDSAP (Medical Device Single Audit Program) certification
MDSAP recognition includes regulatory alignment with:
-
Australia
-
Canada
-
United States
ISO 13485 certification confirms controlled processes for:
-
Product design and development
-
Risk management
-
Production controls
-
Traceability
-
Corrective and preventive actions
New Zealand Regulatory Position
In New Zealand, the Core Series devices are supplied in compliance with electrical safety requirements under the RCM framework.
Regulatory classification may vary depending on intended use and marketing claims.
When marketed for general wellness, cosmetic, aesthetic, or non-specific light exposure applications, these devices may fall outside formal medical device registration requirements.
If marketed for diagnosis, treatment, or prevention of specific diseases or medical conditions, additional regulatory obligations may apply.
We recommend consulting a qualified regulatory advisor if intending to use the device in a clinical or therapeutic healthcare setting.
Transparency & Documentation
Compliance documentation available upon request includes:
-
Global-Mark Certificate of Suitability (AS/NZS 60598)
-
CE EMC & LVD Certificates
-
RoHS Certificate of Conformity
-
ISO 13485 Certification
-
MDSAP Certificate
-
FDA Establishment Registration confirmation
-
IEC 60601 test authorisations (where applicable)
Important Disclaimer
These devices are not represented as a cure or treatment for any specific medical condition unless otherwise stated in accordance with applicable local regulatory approvals.
Information provided on this website is for general informational purposes only and does not constitute medical advice. Users should consult qualified healthcare professionals regarding individual health concerns.
Manufactured by:
E.Shine Systems Limited for Brightside Longevity Limited
Shenzhen, Guangdong, China
The manufacturer operates under ISO 13485 and MDSAP-certified quality systems.
Official certification documentation referencing manufacturer model numbers is available upon request.
