• FDA Class II Medical Device• Condition: New• FDA Clearance: K230342• Availability: In Stock• Use Setting: Clinical / In-Office Use Only The Clinical Photodynamic Therapy System is a FDA-cleared multi-wavelength LED device designed to support light-based treatment applications in MedSpa, dermatology, and aesthetic practice settings. The system uses SMD LEDs across six wavelengths (420nm to 850nm) to activate a topical photosensitizer. Its non-invasive, non-ablative design is intended to support provider-selected light therapy protocols via an intuitive touch-screen interface. PDT Device Features: SMD LED lamp array (1,800–2,400 beads) for uniform coverage. Taiwanese LEDs for extended lifespan and stable output. Multi-wavelength capability: 420nm blue, 469nm blue, 525nm green, 590nm yellow, 633nm red, 830nm–850nm infrared. Adjustable power output and dose range for precision photobiomodulation. Interchangeable treatment heads support single, dual, or tri-color protocols. Touch-screen interface with simple and expert operating modes. Advanced heat-dissipation system for continuous operation. Output intensity: up to 88W total. 12 pre-loaded clinical programs. Manufacturer-Stated Clinical Indications Acne-related applications Rhytid-related applications Pigmentation-related applications Inflammation-related applications Pain-related applications Collagen-associated applications Wound healing-related applications Sports injury-related applications Diabetic ulcer-related applications Additional Features & Options: OEM warranty included All AeonEx clinical devices include U.S.-based training, technical support, and service support A 3-year protection plan is available for added peace of mind. Device onsite installation available Contact us to request a no-cost device expert zoom Indications are provided for product identification only. AeonEx does not verify, endorse, or make clinical, medical, therapeutic, aesthetic, or performance claims for this product. Device Name Omni Photodynamic Therapy System (PDT) OL-950 Product Technology LED / PDT Treatments/Indications Manufacturer-stated indication categories: acne-related, rhytid-related, pigmentation-related, inflammation-related, pain-related, collagen-associated, wound healing-related, sports injury-related, and diabetic ulcer-related applications FDA Status 510k-Cleared K230342 Wavelengths 420nm, 469nm, 525nm, 590nm, 633nm, 830–850nm LED Array 1,800–2,400 SMD beads Max Output 88W Clinical Programs 12 pre-loaded Content Type Product Product Category Devices Clinical Setting Clinical / In-Office Use Only Medical Segment Aesthetics & Dermatology Professional Regulatory Notice & Restricted Device Statement RESTRICTED DEVICE: This device is a professional-grade system. Per 21 CFR 801.109, sale is restricted to licensed healthcare practitioners or authorized clinical facilities. Licensure verification is mandatory prior to order fulfillment. FDA Clearance: K230342
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