| 1 | Device Type and Wavelength | Confirm whether the device uses a laser or intense pulsed light (IPL), and identify the stated wavelength or wavelength range. | Laser safety classification is addressed by IEC 60825-1. IPL equipment is generally evaluated under requirements for non-laser light-source equipment, such as IEC 60601-2-57. | Request the technical specification sheet and verify that the wavelength, light source, and intended use are clearly documented. | Essential |
| 2 | Electrical and Mechanical Safety | Look for protective earth, insulation, leakage-current controls, over-temperature protection, and stable housing construction. | IEC 60601-1 covers basic safety and essential performance for medical electrical equipment. | Ask for the applicable test report or declaration of conformity and inspect cables, connectors, emergency controls, and enclosure quality. | Essential |
| 3 | Regulatory Documentation | Check whether the device has market-specific documentation rather than relying only on marketing terms such as “certified” or “approved.” | In the European Union, CE marking indicates conformity with applicable requirements; in the United States, FDA clearance or authorization is device- and indication-specific. | Verify the declaration, registration, clearance number, intended use, and legal manufacturer in the relevant regulatory database or official documents. | Essential |
| 4 | Skin-Tone Detection and Treatment Limits | Confirm whether the machine identifies unsuitable skin tones, blocks unsafe settings, or provides a documented skin-type operating range. | Melanin absorbs optical energy, so darker or recently tanned skin may require different settings and can have a higher risk of burns or pigmentation changes. | Review the permitted Fitzpatrick skin-type range, contraindications, patch-test procedure, and automatic lockout behavior. | High |
| 5 | Cooling and Contact Protection | Evaluate contact cooling, temperature monitoring, cooling consistency, and whether treatment is disabled without proper skin contact. | Cooling can reduce epidermal heat load and improve comfort, but it does not eliminate the need for correct fluence, pulse duration, and patch testing. | Run a short test sequence and check for contact sensors, temperature indicators, cooling alarms, and automatic shutdown functions. | High |
| 6 | Eye and Operator Protection | Check for wavelength-appropriate protective eyewear, warning indicators, controlled access, and a clearly visible emergency stop. | Laser and intense-light hazards require controls appropriate to the emitted optical radiation and the device’s safety classification. | Verify eyewear markings, optical-density information where applicable, warning labels, key or password access, footswitch behavior, and emergency-stop response. | Essential |
| 7 | Energy and Pulse Controls | Make sure the operator can adjust fluence, pulse duration or pulse structure, repetition rate, and spot size when supported by the device. | Fluence is commonly expressed in J/cm², while pulse duration is commonly expressed in milliseconds. The correct values depend on the device, hair, skin, and treatment area. | Confirm that settings are displayed clearly, limits are locked by software, and the user manual provides protocols instead of unrestricted maximum output. | High |
| 8 | Treatment Applicator and Spot Size | Assess applicator ergonomics, interchangeable tips, spot-size options, beam uniformity, and access to small or curved treatment areas. | A larger spot can improve coverage speed, while a smaller spot can provide better access to narrow areas; optical performance must remain uniform across the spot. | Compare the stated spot dimensions, cable flexibility, handpiece weight, trigger response, and treatment-area coverage during a supervised demonstration. | Medium |
| 9 | User Interface and Treatment Records | Look for role-based access, preset protocols, parameter confirmation, treatment counters, error messages, and data recording. | Clear controls help reduce incorrect settings and support repeatable procedures, but presets should not replace professional assessment or patch testing. | Test whether the system prevents accidental parameter changes, records delivered shots, and identifies alarms in plain language. | Medium |
| 10 | Training, Maintenance, and Risk Management | Confirm operator training, preventive maintenance, calibration, consumable replacement, cleaning procedures, and incident reporting. | ISO 14971 provides a framework for medical-device risk management. Maintenance and calibration requirements are defined by the device manufacturer and applicable regulations. | Request the service schedule, calibration certificate format, training records, warranty terms, spare-parts process, and written adverse-event procedure. | Essential |