Erchonia Corporation - FDA 510(k) Cleared Devices

Erchonia Corporation, is a medical device manufacturer based in Fountain Inn, US, specializing in low-level laser technology for therapeutic applications.

The company has received 26 FDA 510(k) clearances from 26 total submissions, with a regulatory track record spanning 2010 to 2026. Erchonia's cleared devices focus primarily on General & Plastic Surgery and Physical Medicine applications, including laser systems for pain management, fat loss, and tissue healing. The company remains actively engaged in FDA regulatory submissions, with its most recent clearance in 2026.

Erchonia's product portfolio includes multiple generations of low-level laser systems designed for non-invasive therapeutic use. The company positions itself as a leader in FDA-cleared laser technology, with devices spanning cosmetic body contouring, pain relief, and clinical therapeutic applications across multiple medical specialties.

Explore the complete list of Erchonia Corporation FDA 510(k) cleared devices, including model numbers and clearance dates, in the database.

Regulatory submissions have been managed by Regulatory Insight, Inc. and Regulatory Technology Services, LLC. 4 devices have linked clinical trials registered on ClinicalTrials.gov.