Safety Information & Adverse Event Reporting
Onyxa Medical is committed to patient safety. If you have experienced an adverse event or wish to report a concern related to the Junera™ system, please use the resources below.
Report an Adverse Event
Report any adverse event, product complaint, or safety concern directly to our quality and safety team at safety@onyxamed.com. We investigate every report. You may also report adverse events directly to the FDA through the MedWatch Voluntary Reporting program. Healthcare professionals and patients can submit reports online or by phone at 1-800-FDA-1088.
What to Include in Your Report
To help us investigate your report thoroughly, please include as much of the following information as possible: description of the adverse event or concern; date the event occurred; treatment area and fiber size used; treatment parameters including wavelength and power settings; patient outcome and any treatment provided; and contact information for follow-up.
Device Information
Device Name: Junera™ Subdermal Laser System. Manufacturer: Onyxa Medical, Inc. FDA Clearance: 510(k) K212734. Product Code: GEX (21 CFR 878.4810). Classification: Class II Prescription Medical Device. Cleared Indications: soft tissue coagulation, ablation, and laser-assisted lipolysis.
Important Safety Information
The Junera™ system is an FDA-cleared (510(k) K212734) Class II prescription medical device indicated for soft tissue coagulation, ablation, and laser-assisted lipolysis. Aesthetic applications including skin tightening and tissue remodeling are supported by published peer-reviewed clinical studies and are performed at physician discretion. Contraindications include active infection in the treatment area, pregnancy or nursing, history of poor wound healing or keloid formation, bleeding disorders or anticoagulant therapy, and unrealistic patient expectations.
Warnings, Precautions, and Risks
Device must be operated by or under the supervision of a licensed physician. Proper training on the specific fiber optic size and wavelength is required. Local anesthesia administration carries its own risks. Post-procedure compression garments may be required for body treatments. Common side effects include swelling and bruising, tenderness and discomfort at the treatment site, temporary numbness, and mild skin irregularities. Rare but serious risks include thermal burn or injury, scarring, nerve damage, infection, and skin necrosis.
Regulatory Notice
℞ Only — Caution: Federal law restricts this device to sale by or on the order of a licensed physician. Onyxa Medical maintains a complaint handling system in accordance with 21 CFR 820.198 and reports adverse events to the FDA as required under 21 CFR 803 (Medical Device Reporting). This page was last updated February 2026.