Iris PI by Bluecore High-Power Q-Switched Nd:YAG Laser (FDA Cleared K171648)
- $75,000.00
$75,000.00- $75,000.00
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Registered AeonEx Wholesale Club members are eligible for volume discounts of up to 40% on home-use products.
This product may be regulated by the U.S. Food and Drug Administration (FDA), as well as state and local authorities. If applicable, the product is restricted to authorized users only. Should FDA regulations apply, we will confirm your eligibility before shipping. AeonEx retains the right to cancel and refund any transaction prior to shipment at its sole discretion.
Iris PI by Bluecore – High-Power Q-Switched Nd:YAG Laser (FDA Cleared K171648)
- Professional Medical Use Only
- Price: $75,000.00
- Class: II Medical Device
- Condition: New
- FDA Clearance: K171648
- Availability: In Stock (Verification Required)
- Use Setting: Clinical / In-Office Use Only
Professional Regulatory Notice & Restricted Device Statement
RESTRICTED DEVICE: The Iris PI (K171648) 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.
System Overview: The Iris PI by Bluecore is a high-power Q-Switched Nd:YAG platform, the first to utilize 8:2 PTP Bluetoning™ technology. Engineered for stable energy delivery and the safe treatment of dermal pigmented lesions, the system's unique resonator design ensures a True Top Hat Beam Profile. This provides practitioners with uniform energy distribution for consistent clinical outcomes without "hot spots" or adverse textural changes.
Core Technologies & Innovations:
• 8:2 PTP Bluetoning Pro: Delivers 80% of energy in the first pulse and 20% in the second to safely fragment deep pigments while prioritizing the integrity of surrounding dermal tissue.
• Dual Samarium Chambers: Engineered with high-stability dual chambers to ensure consistent energy calibration and long-term laser resonator durability.
• 1800mJ Maximum Energy: Enables the fragmentation of stubborn ink and dermal pigments with industry-leading peak power.
• LIOB-Enabled Fractional Delivery: Utilizing MLA and DOE handpieces, it generates Laser-Induced Optical Breakdown (LIOB) for deep dermal remodeling while leaving the stratum corneum intact.
Notice to Practitioners: The Iris PI (K171648) is cleared for the incision, excision, ablation, and coagulation of soft tissue, as well as the removal of tattoos and pigmented lesions. Specific treatment protocols remain at the discretion of the licensed healthcare provider.
All AeonEx clinical devices come with US-based training and technical/services support.
Technical Specifications Table:
| Device Name | IRIS PI Q-Switched Nd: YAG Laser Aesthetic Device |
| FDA Status | FDA Cleared (K171648) |
| Product Technology | Q-Switched Laser |
| Specific technology | Q-Switched Nd:YAG Laser |
| Treatments/Indications | Ideal laser device for skin rejuvenation treatments and pigmented lesions |
| Wavelengths | 1064nm and 532nm |
| Maximum Energy | 1800mJ (Handpiece) |
| Repetition Rate | Up to 10 Hz [up to 20 Hz for photoacoustic] |
| Peak Power | Approximately 300 MW peak {1.8 J/6 ns} |
| Beam Profile | Super Hive Flat (Top Hat) |
| PTP Technology | 8:2 dual pulses |
| Bluetoning Technology | Unique energy distribution for optimal toning results |
| Handpieces | Zoom, Collimated, MLA, DOE |
| Treatment Modes | Multiple modes for various handpieces |
| Monitoring System | Central monitoring system for easy maintenance |
| Indications | Wide range of conditions, including pigmented lesions |
| Delivery | Laser Induced Optical Breakdown (LIOB) with high energy micro arrays |
| Pulse width | 5 ns Q-switched to 8 ns Q-switched [Photoacoustic Bluetoning pulses {two pulses within 50000 ms}] |
| Spot Size | Zoom 2-10 mm, collimated 7 mm; fractional DOE & MLA tips |
| Cooling System | Internal water cooling with dual filters |
| Device Color | White with colored accents |
| Dimensions | 290 x 793 x 934mm |
| User Interface | "10" touchscreen, Photoacoustic Bluetoning mode, central monitoring |
| Sensors / Safety | Central monitoring system, handpiece detection Key switch, over-temperature sensor and usage lockout card |
| Content Type | Product |
| Product Category | Devices |
| Clinical Setting | Clinic Only |
| Medical Segment | Aesthetics & Dermatology |
The price includes:
1) Shipping cost;
2) Virtual device-use training;
3) Product warranty;
4) Product technical support (USA);
5) US Import tariff;
6) Device use accessories.
Please note that for all detailed payment, logistics, regulatory and tariff questions not covered in the following information, it’s best to reach out to AeonEx directly (info@aesthetics-exchange.com; or via the Contact Us form).
Payment Policy / Information
We accept payments via bank wire transfers, ACH, major credit cards, and ShopPay (installment plans available for purchases up to $30,000). For transactions over $10,000, payment must be made by bank wire or ACH. Our banking details will be provided to you directly for these larger sums. We do not accept payments in cryptocurrency or from PayPal.
For high-value items ($5,000+) we collect a deposit as a first step in purchasing the product. Deposits cancelled within 48 hours from the initial payment are refundable. Beyond that time, we don’t provide deposit refunds for cancellations.
We will contact you directly once the deposit has been registered with us and discuss subsequent payment options and both shipping and delivery dates.
Shipping Policy / Information
We can ship to virtually any address in the continental United States and Canada. We neither sell to - nor ship to - other countries beyond the USA and Canada. We may have shipping special offers - like free shipping - and those will be prominently displayed. Where these are in place they supersede our standard policy. What follows is our standard shipping policy.
Home-Use Products (under 10lbs): When you place an order for a Home-Use item or items - which are mostly under 10lbs - we will estimate shipping and delivery dates for you based on the availability of your items and the shipping options you choose. Please note that the shipping rates for many items we sell are weight-based.
Professional Devices (10lbs and higher): 5-9 Day shipping is standard. The range of 5 to 9 days is based on where the item is shipped from. We have suppliers who are in, and ship from, the USA, but we also work with many European and Asian manufacturers that will ship from their locations. Expedited shipping for items can be provided for an added cost. When you place an order for a professional product, we will estimate the processing time, shipping dates, and delivery dates for you based on availability and the shipping departure point. Shipping rates are freight mode and weight-based.
AeonEx manages shipping and related logistics for customers with our manufacturer and logistics partners. It's our responsibility to get the products to you in compliance with all regulations, including those related to customs clearance and import tariffs. Such import tariffs are always included in professional device pricing.
Returns Policy / Information
We have a 30-day return policy, which means you have 30 days after receiving your item to request a return. We don't charge a restocking fee for home-use products, but deposits on professional devices are not refunded.
To be eligible for a return, your item must be in the same condition that you received it, unworn or unused, with tags, and in its original packaging. You’ll also need the receipt or proof of purchase.
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