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Our Certifications: Committed to Global Safety Standards
Verified quality management systems and product safety credentials for global medical aesthetic markets. As an ISO13485 medical device manufacturer and FDA cleared laser equipment supplier, SEA HEART maintains full regulatory transparency.
Below you'll find official certifications for our diode laser systems, IPL, HIFU, body sculpting devices and more. Every certificate is verifiable and reflects our commitment to safety and efficacy. SEA HEART's quality system is regularly audited to meet FDA 21 CFR 820, ISO 13485, and MDR (EU) 2017/745 requirements.
FDA Cleared Laser & Medical Device Listings
SEA HEART holds multiple FDA clearances for aesthetic and therapeutic devices. As an FDA cleared laser equipment supplier, our devices meet stringent US performance standards.
FDA Establishment Registration & Device Listing (Page 1)
FDA Device Listing – Continuation (Page 2)
CO₂ Laser Therapy System – FDA Cleared
Nd:YAG Laser Therapy System – FDA Cleared
Powered Muscle Stimulator – FDA Cleared
Diode Laser Hair Removal System – FDA Cleared
ISO 13485:2016 – Quality Management System
SEA HEART is a fully certified ISO13485 medical device manufacturer. This internationally recognized standard ensures consistent design, development, production, and distribution of safe medical devices.
ISO 13485:2016 Certificate
European CE Marking & MDR Compliance
All SEA HEART devices comply with the Medical Device Regulation (EU) 2017/745. Our CE certificates confirm conformity with applicable safety and performance requirements.
MDR CE Certificate – Laser Treatment System (Page 1)
CE Certificate – Laser Treatment System (Page 1/2)
CE Certificate – Laser Treatment System (Page 2/2)
MDR CE – Laser Treatment System (Additional Page)
Product‑Specific CE Certificates
Each product category holds its own CE documentation, ensuring device‑specific conformity. Below are certificates for individual systems and accessories.
CE – Diode Laser Hair Removal (Page 1)
CE – Diode Laser Hair Removal (Page 2)
CE – Derma Pen (Microneedling)
CE – HIFU Microneedle Fractional RF
CE – IPL with RF Function
CE – LED Face Masks
CE – Slimming Beauty Massage Machine
CE – HIFEM Body Sculpting (Page 1)
CE – HIFEM Body Sculpting (Page 2)
CE – Electric Derma Pen (Page 1)
CE – Electric Derma Pen (Page 2)
CE – Magic Mirror Skin Analysis
CE – Oxygen / Hydra Dermabrasion (Page 1)
CE – Oxygen / Hydra Dermabrasion (Page 2)
CE – Derma Roller / Skin Roller Series
Request Official Certificate Copies
Need high‑resolution versions for regulatory submissions or distributor verification? Our compliance team provides full certificate packages upon request.
Contact us for certificate copiesWe typically respond within 1 business day. Please specify which certificates you require.
