Inquire
Inquire

Shipping policy

528 Innovations LLC

Effective Date: June 10, 2026

Document ID: POL-QA-0089, Rev. H

Applicability: US Domestic Distribution Only

Welcome to the 528 Innovations LLC website (the "Site"). We manufacture high-performance, precision medical devices, including the 5i Series™ and 528i™ Personal Laser Therapy Systems (with companion handset, battery, and interchangeable laser modules). Because our systems are regulated as Class II Medical Devices and contain Class 3R Laser modules under US Food and Drug Administration (FDA) regulations, our shipping, delivery, and returns processes are governed by strict safety, quality assurance, and traceability requirements.

By purchasing from this Site, you agree to the terms of this Shipping and Distribution Policy.

1. Strictly US-Only Shipping Territory

To maintain full compliance with our cleared indications for use and federal regulatory registrations, 528 Innovations LLC only sells and ships products to addresses within the United States of America (including all 50 states and the District of Columbia). * No International Shipping: We do not ship to US territories (outside the 50 states), APO/FPO/DPO addresses, or international destinations.

  • Freight Forwarding Blocked: We strictly prohibit the shipping of our medical devices to freight forwarding services, third-party export warehouses, or logistics hubs designed to bypass US customs. Any order identified as utilizing a freight-forwarding address will be flagged, held for review, and subject to immediate cancellation.

  • Billing Address Restrictions: Orders must be placed using a credit card or payment method registered with a valid US billing address.

2. Mandatory Delivery Verification & Handheld Laser Safety (Class 3R)

Our 528i™ systems emit visible and invisible laser radiation classified under the FDA's Center for Devices and Radiological Health (CDRH) as Class 3R. Due to the high-intensity optical output:

  • Signature Required: All shipments containing a 528i™ Handset or interchangeable Laser Module (including Red, Infrared, Green, or Violet modules) are shipped via secure carriers with Direct Signature Required at the time of delivery.

  • Delivery Re-routing Restrictions: Carriers are strictly prohibited from leaving shipments unattended on doorsteps, in common yard areas, or in insecure dropboxes. If no recipient is present to sign for the package, the carrier will hold the shipment at a local facility for secure pickup as dictated by carrier terms.

  • User Manual & Safety Literature: Every system shipment contains mandatory FDA-compliant user instructions, safety warning labels, and device configuration guides. The recipient is legally required to review all accompanying documentation prior to unboxing or powering on the laser diode modules.

3. Product Preservation & Standard Transit Validation

The 528i™ platform consists of highly calibrated optical components, sensitive laser diodes, and advanced lithium-polymer battery modules. To satisfy ISO 13485:2016 (Preservation of Product) requirements, we enforce strict protective standards during transit:

  • ASTM-Validated Packaging: All devices are shipped in custom, shock-absorbing protective cases that have been structurally validated under recognized ASTM transport testing standards. This protective packaging is engineered to mitigate physical vibration, drops, and impact forces experienced during standard carrier transit.

  • Expedited & Controlled Methods: We utilize select carrier networks (UPS/FedEx) that guarantee expedited transit timelines. This minimizes the duration that our sensitive laser diodes and lithium-polymer batteries are exposed to variable, unconditioned regional environments during shipping.

  • Storage Limits: If a package is held at a carrier station for pick-up, it must be retrieved within forty-eight (48) hours to prevent prolonged storage in unconditioned warehouses.

4. Unique Device Identifier (UDI) & Serial Number Tracking

Under FDA 21 CFR Part 801 (Subpart B), our medical devices are marked with a Unique Device Identifier (UDI) containing a unique serial number and manufacturing batch code.

  • Chain of Custody: Prior to leaving our Cedar Park, Texas distribution facility, the specific UDI and serial numbers of your Handset, Laser Module, and Battery Module are permanently linked to your order.

  • Traceability Requirement: This serial tracking is mandatory for federal traceability, potential field safety notices, or medical device recalls. By purchasing, you consent to this record-keeping.

5. Damaged Shipments, Quarantine, and QMS Reporting

If your shipping box is severely crushed, punctured, wet, or shows signs of extreme impact, the device's internal optical safety systems or battery safety circuits may be compromised.

  1. Do Not Power On the Device: Under no circumstances should you attempt to plug in, charge, attach modules to, or power on a device that has arrived in a severely damaged shipping container.

  2. Quarantine the Package: Place the damaged box and all internal components in a safe, dry location out of reach of children or pets.

  3. File a Quality Incident Report Immediately: Contact our Quality Assurance Department within twenty-four (24) hours of receipt at support@528innovations.com or via our toll-free support line.

  4. QMS Integration: Once reported, your case will be routed to our Quality Management System (QMS) as an official complaint under 21 CFR Part 820.198. Our engineering team will review the shipment tracking, arrange for a secure return of the damaged unit for diagnostic evaluation, and ship a calibrated replacement.

6. Processing, Lead Times, and Installment Payments

  • Standard Lead Times: Under normal inventory conditions, estimated shipment for standard orders paid in full is within two (2) weeks from the order date.

  • Installment & Financing Orders: For orders utilizing an installment or financing payment structure, final assembly allocation and queue placement will begin only upon receipt and clearance of your final installment payment. Your order is estimated to ship within two (2) weeks of that final payment confirmation.

  • Backorders and Inventory Allocation: Because our systems are specialty medical devices manufactured in highly controlled, low-volume production batches, high consumer demand or component supply constraints may occasionally result in item backorders. In these events:

  • We allocate products strictly on a First-In, First-Out (FIFO) basis based on the order completion timestamp (or final installment payment clearance).

  • If your order goes on backorder, we will immediately contact you via the email address provided at checkout to provide an updated, realistic delivery estimate.

  • FTC Mail Rule Compliance: In accordance with the Federal Trade Commission (FTC) Mail or Telephone Order Merchandise Rule, if a backorder or manufacturing delay pushes your shipping date past our estimated window, we will notify you of the delay, provide a revised shipping date, and give you the option to either consent to the shipping extension or cancel your order for a prompt, full refund.

  • Pre-Dispatch Quality Control Hold: We maintain a zero-compromise policy on safety and calibration. Every individual 528i Handset and Laser Module must pass rigorous quality control release testing under our ISO 13485 Quality Management System before leaving our facility. We will not bypass or accelerate these safety gates for any reason. If an individual unit requires additional calibration, a brief QA hold may occur, and you will be notified accordingly.

  • Shipping Service Levels & Cost Structures:

  • Complimentary Standard Shipping: We provide free Standard Ground Shipping on all orders. Standard shipments are typically routed via UPS Ground (or a comparable secure carrier chosen dynamically based on delivery zip code to optimize transit speed and safety limits). There is no surcharge to the customer for our mandatory Direct Signature Required security handoff on the free standard tier.

  • Accelerated & Expedited Shipping Options: Customers requiring expedited delivery (e.g., 2-Day Air or Overnight) may select these premium options directly at checkout. The associated costs, which fully factor in carrier-mandated direct signature-tracking fees and lithium-polymer battery hazardous materials charges required for air transport of our power/battery modules, will be calculated and added to the order total automatically at checkout. Please note that choosing expedited shipping accelerates carrier transit times but does not bypass or shorten our mandatory pre-dispatch Quality Control hold and final device calibration.

For questions regarding this policy or to report shipment damage, please contact:

528 Innovations LLC Quality Assurance & Regulatory Compliance

1405 Arrow Point Dr., Suite 1101

Cedar Park, TX 78613

Email: support@528innovations.com