Stellar M22

The Stellar M22 is a multi-application laser and intense pulsed light (IPL) system for aesthetic dermatology procedures. It offers four interchangeable handpieces (IPL, Multi-Spot Nd:YAG, ResurFX, and Q-Switched Nd:YAG) to treat various skin conditions including benign lesions, vascular lesions, unwanted hair, acne, wrinkles, tattoos, and pigmented lesions across skin types I-V.

The subject device has identical wavelengths (400–1200 nm), maximum energy (up to 40 or 70 mJ per microbeam), handpiece configuration, and accessories as the predicate K193500. The primary modification is the addition of new hardware for secure cloud-based transmission of technical data to enable remote service and problem-solving capabilities, while maintaining the same clinical functionality and treatment specifications.

Risk analysis per ISO 14971; electrical, laser and electromagnetic compatibility safety testing per IEC 60601-1 and IEC 60601-1-2; software verification and validation per IEC 62304 and FDA Guidance on Software Validation (January 2002); and system testing for performance, functionality, and communication.

The modifications introduced are hardware-only additions for remote service infrastructure and do not alter the device's intended use, clinical indications, wavelengths, energy outputs, or treatment handpieces. Because the subject device performs identically to the predicate (K193500) in all clinically relevant parameters and the added cloud connectivity hardware does not change safety or effectiveness profiles, the subject device is substantially equivalent. No new clinical validation was required because the predicate's clinical validation directly applies to the subject device.