Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)

The GD-P-E is a handheld, non-invasive, non-heating infrared laser device that emits dual wavelengths (808nm and 650nm) for adjunctive pain relief. It is indicated for temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin, and minor chronic pain associated with Carpal Tunnel Syndrome.

The subject device produces 13 × 650nm laser diodes and 4 × 808nm laser diodes with output power of 5mW (650nm) and 3mW (808nm), operates in 5 or 8 minute timing modes, and delivers 1773.15 mJ/mm² energy fluence via a handheld treatment probe with pulsed and continuous modulation capability. It uses a 3.7V lithium-ion battery and is Class 3R at the aiming beam.

IEC 60601-1:2020 (medical electrical equipment general requirements), IEC 60601-1-2:2020 (electromagnetic compatibility), IEC 60825-1:2014 (laser product safety), IEC 60601-1-11:2020 (home healthcare equipment), 21 CFR Part 1010 (electronic product radiation), FCC 47 CFR Part 15B, and UL approval.

The device is substantially equivalent because it shares the same intended use (adjunctive pain relief for neck/shoulder pain and carpal tunnel syndrome), same regulatory classification (Class II, 21 CFR 890.5500), same product code (NHN), and same mode of operation (non-heating handheld infrared laser therapy) as the predicate devices. Performance testing demonstrates the subject device's minor technological differences in wavelength combinations and power output do not raise different safety or effectiveness questions, and compliance with accepted consensus standards confirms it performs as intended.